U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Products and Medical Procedures
  4. Device Approvals, Denials and Clearances
  5. 510(k) Clearances
  6. December 2018 510(k) Clearances
  1. 510(k) Clearances

December 2018 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD December 2018


DEVICE: AirSpiral Heated Breathing Tube
	FISHER & PAYKEL HEALTHCARE        	510(k) NO: K162553(Traditional)
	ATTN: STEPHANIE  ELVIN            	PHONE NO : 64 9 5740100 
	15 MAURICE PAYKEL PLACE, EAST TAMA	SE DECISION MADE: 20-DEC-18
	AUCKLAND  NZ 2013                 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: RII Smart IR Thermometer
	RADIANT INNOVATION INC.           	510(k) NO: K163601(Traditional)
	ATTN: Monica  Chung               	PHONE NO : 886 3 6111666 
	1F, NO. 3 INDUSTRIAL E. 9TH RD SCI	SE DECISION MADE: 06-DEC-18
	HSIN CHU  TW 30075                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Neck Care Therapy, Model: SYK 509B
	Shenzhen OSTO Technology Co., Ltd.	510(k) NO: K172897(Traditional)
	ATTN: Li  Yang                    	PHONE NO : 86 755 29769546 
	No.43 Longfeng Road, Xinsheng Comm	SE DECISION MADE: 07-DEC-18
	Shenzhen  CN                      	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Handheld VitalSigns Monitoring System
	Visiomed Technology Co.,Ltd       	510(k) NO: K172965(Traditional)
	ATTN: Chen  XiaoFeng              	PHONE NO : 07 55 29481701 
	2 Floor of No.1 Building, Jia An T	SE DECISION MADE: 17-DEC-18
	Bao An, Shenzhen,  CN 518000      	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: North-vision Multi-parameter Patient Monitor
	North-vision Tech. Inc.           	510(k) NO: K173036(Traditional)
	ATTN: Albert  Huang               	PHONE NO : 886 3 5771038 
	1st Fl., No.15, Gongye E. 2nd Rd.,	SE DECISION MADE: 21-DEC-18
	Hsinchu City  TW 30075            	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: 3DIEMME RealGUIDE
	3DIEMME Ltd.                      	510(k) NO: K173041(Traditional)
	ATTN: Alessandro  Montroni        	PHONE NO : 39 031 7073353 
	Via Risorgimento 9                	SE DECISION MADE: 20-DEC-18
	Cantu  IT 22063                   	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: No-contact Forehead Thermometer
	Dongguan SIMZO Electronic Technolo	510(k) NO: K173048(Traditional)
	ATTN: Mei  Mei                    	PHONE NO : 86 769 86339010 
	No.81, Tianxin Street, Chongkong, 	SE DECISION MADE: 06-DEC-18
	Dongguan  CN                      	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: IMPLANTER DENTAL PLANNING SOFTWARE
	Implanter LLC                     	510(k) NO: K173083(Traditional)
	ATTN: Jorge  Millan               	PHONE NO : 786 4165587 
	2801 NE 183rd St #110W            	SE DECISION MADE: 03-DEC-18
	Aventura FL  33160                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System
	VivaChek Laboratories, Inc.       	510(k) NO: K173140(Traditional)
	ATTN: Julie  Zhou                 	PHONE NO : 302 3398107 
	913 N Market Street, Suite 200    	SE DECISION MADE: 19-DEC-18
	Wilmington DE  19081              	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: reSET-O
	Pear Therapeutics, Inc.           	510(k) NO: K173681(Traditional)
	ATTN: Yuri  Maricich              	PHONE NO : 617 4337327 
	745 Atlantic Ave.                 	SE DECISION MADE: 10-DEC-18
	Boston MA  02111                  	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: REXLENE
	SM ENG CO., LTD                   	510(k) NO: K173747(Traditional)
	ATTN: Soon-Gu  Lee                	PHONE NO : 82 51 3058016 
	46, Nakdong-daero 1302beon-gil    	SE DECISION MADE: 21-DEC-18
	Sasang-gu  KR 46910               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: AMRA Profiler
	AMRA Medical AB                   	510(k) NO: K173749(Traditional)
	ATTN: Janne  West                 	PHONE NO : 46 13 162600 
	Badhusgatan 5                     	SE DECISION MADE: 06-DEC-18
	Linkoping  SE 58222               	510(k) STATEMENT
	                                                    

DEVICE: SCIg60 Infusion System
	EMED Technologies Corporation     	510(k) NO: K173783(Traditional)
	ATTN: Peter  Kollings             	PHONE NO : 916 9320071 
	1264 Hawks Flight Ct, Suite 200   	SE DECISION MADE: 14-DEC-18
	El Dorado Hills CA  95762         	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Creme de La Femme Feminine Lubricant
	Cewal, Inc. dba Premiere Enterpris	510(k) NO: K180014(Traditional)
	ATTN: Jerome  Vozoff              	PHONE NO : 310 8395000 
	2806 Oakhurst Avenue              	SE DECISION MADE: 21-DEC-18
	Los Angeles CA  90034             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: SignalMark Lung Biopsy Site Marker
	ViewPoint Medical, Inc.           	510(k) NO: K180175(Traditional)
	ATTN: Thomas  Kane                	PHONE NO : 760 7077901 
	1235 Puerta del Sol #600          	SE DECISION MADE: 07-DEC-18
	San Clemente CA  92673            	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: CranioMaxillofacial Fixation (CMF) System - CMF Visionare
	Visionare LLC                     	510(k) NO: K180204(Traditional)
	ATTN: Mariane  de Oliveira Quinzan	PHONE NO : 1 239 2442973 
	12251 Towne Lake Drive            	SE DECISION MADE: 28-DEC-18
	Fort Meyers FL  33913             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: BTL-FR2000
	BTL Industries, Inc.              	510(k) NO: K180359(Traditional)
	ATTN: David  Chmel                	PHONE NO : 1 866 2851656 
	362 Elm Street                    	SE DECISION MADE: 13-DEC-18
	Marlborough MA  01752             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: vital signs monitor
	Edan Instruments, Inc.            	510(k) NO: K180380(Traditional)
	ATTN: Alice  Yang                 	PHONE NO : 86 755 26858736 
	#15 Jinhui Road,Jinsha Community K	SE DECISION MADE: 21-DEC-18
	Shenzhen  CN 518122               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Procellera Composite Antibacterial Wound Dressing
	Vomaris Wound Care, Inc.          	510(k) NO: K180533(Traditional)
	ATTN: Charmaine  Sutton           	PHONE NO : 480 9214948 
	1911 East Fifth Street            	SE DECISION MADE: 10-DEC-18
	Tempe AZ  85281                   	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Harvest Dental Polymer Blocks
	Harvest Dental Products, LLC      	510(k) NO: K180578(Traditional)
	ATTN: Sasha  Der Avanessian       	PHONE NO : 714 6747400 
	905 Columbia Street               	SE DECISION MADE: 12-DEC-18
	Brea CA  92821                    	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
	Fresenius Kabi USA LLC            	510(k) NO: K180615(Traditional)
	ATTN: Kim  Forch                  	PHONE NO : 847 5507962 
	Three Corporate Drive             	SE DECISION MADE: 04-DEC-18
	Lake Zurich IL  60047             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Spartan eCoil System
	Spartan Micro, Inc                	510(k) NO: K180653(Traditional)
	ATTN: Mark  Dias                  	PHONE NO : 512 2708501 
	3167 Skyway Court                 	SE DECISION MADE: 04-DEC-18
	Freemont CA  94539                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Resin for Temporary Crown & Bridge
	Dentis Co., Ltd.                  	510(k) NO: K180657(Traditional)
	ATTN: Dong-Hun  Jang              	PHONE NO : 82 53 5832804 
	6, Yuram-ro, Dong-gu              	SE DECISION MADE: 07-DEC-18
	Daegu  KR 41065                   	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: ICONN Campbell Interference Screw
	ICONN Orthopedics, LLC            	510(k) NO: K180670(Traditional)
	ATTN: Whitt  Israel               	PHONE NO : 205 9132068 
	400 Union Hill Drive, Suite 150   	SE DECISION MADE: 07-DEC-18
	Birmingham AL  35209              	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate)
	Global Scientific Technologies, LL	510(k) NO: K180679(Traditional)
	ATTN: William J. Griswold, Jr.    	PHONE NO : 864 6553590 
	151 Old Jones Road                	SE DECISION MADE: 07-DEC-18
	Greer SC  29651                   	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: C-Zero Pedicle Screw System, Freedom Pedicle Screw System
	Signature Orthopaedics Pty Ltd.   	510(k) NO: K180754(Traditional)
	ATTN: Declan  Brazil              	PHONE NO : 61 2 94285181 
	7 Sirius Road                     	SE DECISION MADE: 07-DEC-18
	Lane Cove  AU 2066                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: CAPI 3 HEMOGLOBIN(E)
	SEBIA                             	510(k) NO: K180762(Traditional)
	ATTN: Karen  Anderson             	PHONE NO : 770 4463707 3704
	1705 Corporate Drive, Suite 400   	SE DECISION MADE: 14-DEC-18
	Norcross GA  30093                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Arthrex SwiveLock Anchors
	Arthrex Inc.                      	510(k) NO: K180768(Traditional)
	ATTN: Jessica L. Singelais        	PHONE NO : 1 239 5984302 73091
	1370 Creekside Boulevard          	SE DECISION MADE: 14-DEC-18
	Naples FL  34108-1945             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Met One Czar Anterior Cervical Plate System
	Met One Technologies              	510(k) NO: K180772(Traditional)
	ATTN: Evan  Carbonell             	PHONE NO : 
	154 N. Festival Dr. Villa F       	SE DECISION MADE: 17-DEC-18
	El Paso TX  79912                 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Xcess Guiding Catheter
	Curatia Medical Co.               	510(k) NO: K180797(Traditional)
	ATTN: Jessica  Chiu               	PHONE NO : 408 4142188 
	3227 Kifer Road                   	SE DECISION MADE: 14-DEC-18
	Santa Clara CA  95051             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Tono Vue Non-Contact Tonometer
	Crystalvue Medical Corporation    	510(k) NO: K180820(Traditional)
	ATTN: Oliver  Lin                 	PHONE NO : 886 3 3607711 
	No. 116, Ln.956, Zhongshan Rd., Ta	SE DECISION MADE: 14-DEC-18
	Taoyuan  TW 33072                 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: TruMatch Graft Cage - Long Bone
	Synthes (USA) LLC                 	510(k) NO: K180821(Traditional)
	ATTN: Christopher J. Medberry     	PHONE NO : 610 7196806 
	1301 Goshen Parkway               	SE DECISION MADE: 21-DEC-18
	West Chester PA  19380            	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Natrelle 133 Plus MICROCELL Tissue Expander
	Allergan                          	510(k) NO: K180826(Traditional)
	ATTN: Melissa  Pathmajeyan        	PHONE NO : 714 2465919 
	2525 Dupont Drive                 	SE DECISION MADE: 21-DEC-18
	Irvine CA  92612                  	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Natureplex Warm Touch Warming Jelly
	Natureplex, LLC                   	510(k) NO: K180828(Traditional)
	ATTN: Pamela  Hopkins             	PHONE NO : 662 8741206 
	11085 Airport Road                	SE DECISION MADE: 20-DEC-18
	Olive Branch MS  38654            	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Reuter Tip Deflecting Wire Guide
	Cook Incorporated                 	510(k) NO: K180830(Traditional)
	ATTN: Jennifer L. Allman          	PHONE NO : 812 3353575 104280
	750 Daniels Way                   	SE DECISION MADE: 20-DEC-18
	Bloomington IN  47402             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: CATSmart
	Fresenius Kabi AG                 	510(k) NO: K180831(Traditional)
	ATTN: Barry G. Hicks              	PHONE NO : 49 6172 6860 
	Else-Kroner-Strasse 1             	SE DECISION MADE: 10-DEC-18
	Bad Homburg  DE 61352             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Arterial Pressure Monitoring Set/Tray
	Cook Incorporated                 	510(k) NO: K180846(Traditional)
	ATTN: Johnathan  Liu              	PHONE NO : 812 3353575 104509
	750 Daniels Way                   	SE DECISION MADE: 19-DEC-18
	Bloomington IN  47404             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: PYRAMIDION Dental Implants and Prostheses
	DenTack Implants Ltd              	510(k) NO: K180859(Traditional)
	ATTN: Tali  Hazan                 	PHONE NO : 972 50 5292304 
	24 HaTa'as St. POB 2405           	SE DECISION MADE: 13-DEC-18
	Kfar-Saba  IL 4464102             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator
	TaiDoc Technology Corporation     	510(k) NO: K180863(Traditional)
	ATTN: Sylvia  Liu                 	PHONE NO : 886 2 66258188 6134
	6F, No.127, Wugong 2nd Rd., Wugu D	SE DECISION MADE: 19-DEC-18
	New Taipei City  TW 24888         	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: AmCAD-UO
	AmCad BioMed Corporation          	510(k) NO: K180867(Traditional)
	ATTN: Jack  Yang                  	PHONE NO : 886 2 27136227 
	FL. 5-2, No. 167, Fu Hsing N. RD. 	SE DECISION MADE: 28-DEC-18
	Taipei  TW 105                    	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use
	Shanghai Venture Bio-Tech CO., Ltd	510(k) NO: K180878(Traditional)
	ATTN: Longli  Long                	PHONE NO : 86 21 34621799 
	Room 313, Building 2, No. 2715 Lon	SE DECISION MADE: 17-DEC-18
	Shanghai  CN 200231               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use
	SHANGHAI VENTURE BIO-TECH CO., LTD	510(k) NO: K180879(Traditional)
	ATTN: Longli  Long                	PHONE NO : 86 21 34621799 
	Room 313, Building 2, No. 2715 Lon	SE DECISION MADE: 14-DEC-18
	Shanghai  CN 200231               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Tractus Crossing Support Catheter
	Tractus Vascular LLC              	510(k) NO: K180889(Traditional)
	ATTN: Janet  Burpee               	PHONE NO : 732 9968513 
	15 Christopher Way                	SE DECISION MADE: 07-DEC-18
	Eatontown NJ  07724               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: REVEL Spacers
	Globus Medical Inc.               	510(k) NO: K180909(Traditional)
	ATTN: Kelly J. Baker              	PHONE NO : 610 9301800 1670
	2560 General Armistead Avenue     	SE DECISION MADE: 18-DEC-18
	Audubon PA  19403                 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: LUTRONIC GENIUS Radiofrequency System
	Lutronic Corporation              	510(k) NO: K180945(Traditional)
	ATTN: Jhung Won Vojir             	PHONE NO : 82 31 9083440 
	Lutronic Center, 219, Sowon-ro    	SE DECISION MADE: 10-DEC-18
	Deogyang-gu, Goyang-si  KR 410220 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Mygen V-1000 RF System
	RF Medical Co., Ltd               	510(k) NO: K180999(Traditional)
	ATTN: Kwang S. Choi               	PHONE NO : 82 2 21084200 
	#502, 503, 506, 511, 254, Beotkkot	SE DECISION MADE: 11-DEC-18
	Seoul  KR                         	510(k) STATEMENT
	                                                    

DEVICE: DIO CAD/CAM Abutment
	DIO Corporation                   	510(k) NO: K181037(Traditional)
	ATTN: Jiae  Park                  	PHONE NO : 82 51 7457836 
	66, Centum Seo-ro, Haeundae-gu    	SE DECISION MADE: 21-DEC-18
	Busan  KR 48058                   	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Apex Locator, DPEX III
	Guilin Woodpecker Medical Instrume	510(k) NO: K181087(Traditional)
	ATTN: Xunxian  Wu                 	PHONE NO : 86 773 2269636 
	Information Industrial Park, Guili	SE DECISION MADE: 18-DEC-18
	Guilin City  CN 541004            	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Elevo® Kit Snoring Intervention Device
	Zelegent, Inc.                    	510(k) NO: K181107(Traditional)
	ATTN: David C. Humbert            	PHONE NO : 650 7638282 
	5151 California Avenue            	SE DECISION MADE: 06-DEC-18
	Irvine CA  92617                  	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: 2.8 mm/3.3 mm PopLok Suture Anchors
	ConMed Corporation                	510(k) NO: K181120(Special)
	ATTN: Diana L. Nader-Martone      	PHONE NO : 727 3995264 
	525 French Road                   	SE DECISION MADE: 21-DEC-18
	Utica NY  13502                   	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Accu-Chek Guide Me Blood Glucose Monitoring System
	Roche Diabetes Care               	510(k) NO: K181131(Special)
	ATTN: Ginger  Emrich              	PHONE NO : 317 5214037 
	9115 Hague Road                   	SE DECISION MADE: 13-DEC-18
	Indianapolis IN  46250            	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: LZI Fentanyl Enzyme Immunoassay
	Lin-Zhi International, Inc.       	510(k) NO: K181159(Traditional)
	ATTN: Bernice  Lin                	PHONE NO : 408 9708811 
	2945 Oakmead Village Court        	SE DECISION MADE: 03-DEC-18
	Santa Clara CA  95051             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Cardinal Health Sterilization Wrap
	Cardinal Health 200 LLC           	510(k) NO: K181174(Traditional)
	ATTN: Jillian  Connery            	PHONE NO : 614 7574045 
	3651 Birchwood Drive              	SE DECISION MADE: 11-DEC-18
	Waukegan IL  60085                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: DePuy Synthes T-PAL Spacer System
	DePuy Synthes Spine               	510(k) NO: K181231(Traditional)
	ATTN: Heta  Shah                  	PHONE NO : 508 9773966 
	325 Paramount Drive               	SE DECISION MADE: 06-DEC-18
	Raynham MA  02767                 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: iCertainty
	Rfpi                              	510(k) NO: K181269(Traditional)
	ATTN: Jeffery  Basham             	PHONE NO : 919 2802953 
	1800 N Greene Street, Suite K     	SE DECISION MADE: 14-DEC-18
	Greenville NC  27834              	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Honda Walking Assist Device
	Honda Motor Company, Ltd.         	510(k) NO: K181294(Traditional)
	ATTN: Kazushi  Hamaya             	PHONE NO : 81 80 49004527 
	1-4-1 Chuo                        	SE DECISION MADE: 14-DEC-18
	Wako-shi  JP 351-0193             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White
	Juvora, Ltd.                      	510(k) NO: K181331(Traditional)
	ATTN: Tim  Leyva                  	PHONE NO : 484 3544185 
	Technology Centre, Hillhouse Inter	SE DECISION MADE: 21-DEC-18
	Thornton-Clevelys  GB FY5 4QD     	510(k) STATEMENT
	                                                    

DEVICE: HS50 / HS60 Diagnostic Ultrasound System
	Samsung Medison Co., Ltd.         	510(k) NO: K181336(Traditional)
	ATTN: Ji Yea Lee                  	PHONE NO : 82 2 21941594 
	3366, Hanseo-ro, Nam-myeon        	SE DECISION MADE: 04-DEC-18
	Hongcheon-gun  KR 25108           	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: C.T.M Mobility Scooter
	CHIEN TI ENTERPRISE CO., LTD.     	510(k) NO: K181344(Traditional)
	ATTN: Vivian  Lo                  	PHONE NO : 886 2 29032987 
	No. 13, Lane 227, Fu Ying Rd      	SE DECISION MADE: 14-DEC-18
	New Taipei City, Hsin Chuang Distr	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: PATRIOT® Lumbar Spacers, SUSTAIN® Spacers
	Globus Medical Inc.               	510(k) NO: K181357(Traditional)
	ATTN: Kelly  Baker                	PHONE NO : 610 9301800 1670
	2560 General Armistead Ave.       	SE DECISION MADE: 06-DEC-18
	Audubon PA  19403                 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Argos
	Retia Medical, LLC                	510(k) NO: K181372(Traditional)
	ATTN: Marc  Zemel                 	PHONE NO : 914 5941986 
	7 Dana Rd. Suite 111              	SE DECISION MADE: 13-DEC-18
	Valhalla NY  10595                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: NRFit Syringe
	Jiangsu Caina Medical Co., Ltd    	510(k) NO: K181374(Traditional)
	ATTN: Jun  Lu                     	PHONE NO : 86 510 86205183 
	No. 23, Huanxi Road, Zhutang Town 	SE DECISION MADE: 14-DEC-18
	Jiangyin  CN 214421               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Hailie Sensor
	Adherium (NZ) Ltd                 	510(k) NO: K181405(Traditional)
	ATTN: Chris  Mander               	PHONE NO : 64 9 3072771 
	Level 2, 204 Quay Street          	SE DECISION MADE: 10-DEC-18
	Auckland  NZ 1010                 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: VITEK MS
	bioMerieux, Inc.                  	510(k) NO: K181412(Traditional)
	ATTN: Jennifer  Jines             	PHONE NO : 314 7318352 
	595 Anglum Rd.                    	SE DECISION MADE: 21-DEC-18
	Hazelwood MO  63042               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: DuraSheath Introducer Sheath System
	Contract Medical International Gmb	510(k) NO: K181463(Traditional)
	ATTN: Jan  Kloboucnik             	PHONE NO : 49 3512138888 
	Lauensteiner Str. 37              	SE DECISION MADE: 13-DEC-18
	Dresden  DE 01277                 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: VINTAGE PRO
	Shofu Dental Corporation          	510(k) NO: K181496(Traditional)
	ATTN: Mauro  Malzyner             	PHONE NO : 760 7363277 202
	1225 Stone Drive                  	SE DECISION MADE: 18-DEC-18
	San Marcos CA  92078              	510(k) STATEMENT
	                                                    

DEVICE: X-ray Imaging System for the McLaren Proton Treatment System
	EhmetDx, LLC                      	510(k) NO: K181498(Traditional)
	ATTN: Daniel  Schoettlin          	PHONE NO : 614 9057161 
	47801 W Anchor Ct                 	SE DECISION MADE: 10-DEC-18
	Plymouth MI  48170                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection
	Contego Medical, LLC              	510(k) NO: K181529(Traditional)
	ATTN: Elizabeth  Saylors          	PHONE NO : 919 4597250 
	3921 Sunset Ridge Rd., Suite 102  	SE DECISION MADE: 06-DEC-18
	Raliegh NC  27607                 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Arthrex Fracture Adapter Hemi Shoulder Prosthesis
	Arthrex Inc.                      	510(k) NO: K181555(Traditional)
	ATTN: David L. Rogers             	PHONE NO : 239 6435553 71924
	1370 Creekside Boulevard          	SE DECISION MADE: 21-DEC-18
	Naples FL  34108-1945             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20
	Flexicare Medical Limited         	510(k) NO: K181583(Third Party - Traditional)
	ATTN: Joel  Biddle                	PHONE NO : 44 1443 474560 
	Cynon Valley Business Park        	SE DECISION MADE: 07-DEC-18
	Mountain Ash  GB cf45 4ER         	510(k) SUMMARY AVAILABLE FROM FDA
	                                  THIRD PARTY REVIEW

DEVICE: Curiteva Lumbar Interbody Fusion System
	Curiteva, LLC                     	510(k) NO: K181589(Traditional)
	ATTN: Eric  Linder                	PHONE NO : 256 2131057 
	25127 Will McComb Drive, Suite 100	SE DECISION MADE: 20-DEC-18
	Tanner AL  35671                  	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Tyto Stethoscope (OTC)
	Tyto Care Ltd.                    	510(k) NO: K181612(Third Party - Traditional)
	ATTN: Stella Raizelman  Perry     	PHONE NO : 972 72 2210750 
	12 Haomanut Street                	SE DECISION MADE: 17-DEC-18
	Netanya  IL 4250445               	510(k) SUMMARY AVAILABLE FROM FDA
	                                  THIRD PARTY REVIEW

DEVICE: Life Spine Resolute™ Threaded Cage System
	Life Spine Inc.                   	510(k) NO: K181625(Traditional)
	ATTN: Angela  Batke               	PHONE NO : 847 8846117 
	13951 S Quality Drive             	SE DECISION MADE: 11-DEC-18
	Huntley IL  60142                 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: QuikClot Radial
	Z-Medica, LLC                     	510(k) NO: K181641(Traditional)
	ATTN: Sheila K. Wallin            	PHONE NO : 203 7747922 
	4 Fairfield Boulevard             	SE DECISION MADE: 24-DEC-18
	Wallingford CT  06492             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
	GenMark Diagnostics, Incorporated 	510(k) NO: K181663(Traditional)
	ATTN: Alan  Maderazo              	PHONE NO : 760 4484308 
	5964 La Place Court               	SE DECISION MADE: 20-DEC-18
	Carlsbad CA  92008                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System
	TaiDoc Technology Corporation     	510(k) NO: K181675(Traditional)
	ATTN: Yvette  Chang               	PHONE NO : 866 2 66258188 
	B1-7F, No. 127, Wugong 2nd Rd., Wu	SE DECISION MADE: 10-DEC-18
	New Taipei City  TW 24888         	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Clear-Jet Injection Catheter
	Finemedix Co. Ltd.                	510(k) NO: K181690(Traditional)
	ATTN: Hee Kyung Kwon              	PHONE NO : 82 53 7418388 
	60, Maeyeo-ro, Dong-gu            	SE DECISION MADE: 21-DEC-18
	Daegu  KR 41065                   	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Nihon Kohden NKV-550 Series Ventilator System
	Nihon Kohden OrangeMed, Inc.      	510(k) NO: K181695(Traditional)
	ATTN: Sheryl  Higgins             	PHONE NO : 949 5026448 
	1800 E. Wilshire Ave.             	SE DECISION MADE: 07-DEC-18
	Santa Ana CA  92705               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments
	Institut Straumann AG             	510(k) NO: K181703(Traditional)
	ATTN: Viviana  Horhoiu            	PHONE NO : 41 61 9651512 
	Peter Merian Weg 12               	SE DECISION MADE: 28-DEC-18
	Basel  CH CH-4002                 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Vivid iq
	GE Medical Systems Ultrasound and 	510(k) NO: K181727(Traditional)
	ATTN: Tracey  Ortiz               	PHONE NO : 262 4701003 
	9900 W. Innovation Drive          	SE DECISION MADE: 06-DEC-18
	Wauwatosa WI  53226               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: BI-MENTUM dual mobility system
	Serf                              	510(k) NO: K181744(Traditional)
	ATTN: Jean-Lus  Aurelle           	PHONE NO : 33 472 056010 
	85 Avenue des Bruyeres            	SE DECISION MADE: 11-DEC-18
	Decines  FR 69150                 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)
	Stryker Corporation               	510(k) NO: K181752(Traditional)
	ATTN: Kristi  Ashton              	PHONE NO : 269 3895929 
	4100 E. Milham Avenue             	SE DECISION MADE: 21-DEC-18
	Kalamazoo MI  49001               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle
	AprioMed AB                       	510(k) NO: K181756(Traditional)
	ATTN: Katrin  Svensson            	PHONE NO : 46 184 301440 
	Virdings Alle 28                  	SE DECISION MADE: 18-DEC-18
	Uppsala  SE 75450                 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Zimmer Biomet Select Ceramic Heads
	Zimmer, Inc                       	510(k) NO: K181761(Traditional)
	ATTN: Carol  Vierling             	PHONE NO : 706 4762938 
	PO Box 708                        	SE DECISION MADE: 26-DEC-18
	Warsaw IN  46581-0708             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance
	bioMerieux, Inc                   	510(k) NO: K181766(Traditional)
	ATTN: Cherece L. Jones            	PHONE NO : 314 7318684 
	595 Anglum Rd.                    	SE DECISION MADE: 10-DEC-18
	Hazelwood MO  63042               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Modified BrainScope One
	BrainScope Company Inc.           	510(k) NO: K181785(Traditional)
	ATTN: Michael E Singer            	PHONE NO : 240 7527680 
	4350 East West Hwy, Ste 1050      	SE DECISION MADE: 19-DEC-18
	Bethesda MD  20814                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: CBT Screw Fixation System
	U&i Corporation                   	510(k) NO: K181824(Traditional)
	ATTN: Jee-Ae  Bang                	PHONE NO : 82 31 8606846 
	20, Sandan-ro 76beon-gil(Rd)      	SE DECISION MADE: 13-DEC-18
	Uijeongbu-si  KR 11781            	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: CAAS MR Solutions
	Pie Medical Imaging B.V.          	510(k) NO: K181825(Traditional)
	ATTN: Annemiek  Bouts             	PHONE NO : 31 433 281328 
	Philipsweg 1                      	SE DECISION MADE: 04-DEC-18
	Maastricht  NL 6227 AJ            	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Glenoid Polyaxial Non-locking Screws
	Medacta International SA          	510(k) NO: K181826(Traditional)
	ATTN: Stefano  Baj                	PHONE NO : 41 91 6966060 
	Strada Regina                     	SE DECISION MADE: 10-DEC-18
	Castel San Pietro  CH CH-6874     	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Affixus Natural Nail System Humeral Nail
	Zimmer GmbH                       	510(k) NO: K181827(Traditional)
	ATTN: Robert  Tommasini           	PHONE NO : 41 58 8548264 
	Sulzerallee 8                     	SE DECISION MADE: 14-DEC-18
	Winterthur  CH 8404               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Sinusway Dilation System
	3NT Medical Ltd.                  	510(k) NO: K181838(Traditional)
	ATTN: Ehud  Bendory               	PHONE NO : 972 737154057 
	22 Hamelacha Street PO Box 11384  	SE DECISION MADE: 20-DEC-18
	Rosh Ha'ayin  IL 4809169          	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Embrace
	Empatica Srl                      	510(k) NO: K181861(Traditional)
	ATTN: Simone  Tognetti            	PHONE NO : 0039 334 3078626 
	Via Stendhal 36                   	SE DECISION MADE: 20-DEC-18
	Milano  IT 20144                  	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Acu-sInQ Complete Endoscope Cleaning Aid System
	STERIS Corporation                	510(k) NO: K181865(Traditional)
	ATTN: Gregory  Land               	PHONE NO : 440 3927424 
	5960 Heisley Road                 	SE DECISION MADE: 14-DEC-18
	Mentor OH  44060                  	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: On1 Universal Abutment
	Nobel Biocare AB                  	510(k) NO: K181869(Traditional)
	ATTN: Charlemagne  Chua           	PHONE NO : 714 2824800 7830
	Box 5190, SE-402 26, Vastra Hamnga	SE DECISION MADE: 12-DEC-18
	Goteborg  SE SE-411 17            	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Phoenix 2.4mm Atherectomy Plus System
	Volcano AtheroMed Inc.            	510(k) NO: K181877(Traditional)
	ATTN: Jean  Chang                 	PHONE NO : 650 3525255 
	1530 O'Brien Drive Suite A        	SE DECISION MADE: 17-DEC-18
	Menlo Park CA  94025              	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: ROCCIA® PLIF
	Silony Medical GmbH               	510(k) NO: K181899(Traditional)
	ATTN: Bircan  Tasdelen            	PHONE NO : 49 711 7825250 
	Leinfelder Strasse 60             	SE DECISION MADE: 13-DEC-18
	Leinfelden-Echterdingen  DE 70771 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Action Trackchair
	Action Manufacturing Inc.         	510(k) NO: K181908(Traditional)
	ATTN: Alan  Macht                 	PHONE NO : 507 5325940 
	1105 Lake Road                    	SE DECISION MADE: 03-DEC-18
	Marshall MN  56258                	510(k) STATEMENT
	                                                    

DEVICE: Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker
	CooperVision, Inc.                	510(k) NO: K181920(Traditional)
	ATTN: Marie  Dutton               	PHONE NO : 925 2516645 
	5870 Stoneridge Drive Suite 1     	SE DECISION MADE: 11-DEC-18
	Pleasanton CA  94588              	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Endoform Reconstructive Template - Non Absorbable
	Aroa Biosurgery Ltd.              	510(k) NO: K181935(Traditional)
	ATTN: Tina  O'Brien               	PHONE NO : 64 09 8693035 
	2 Kingsford Smith Place           	SE DECISION MADE: 04-DEC-18
	Airport Oaks  NZ 2022             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: MagnetOs Putty
	Kuros Biosciences B.V.            	510(k) NO: K181958(Traditional)
	ATTN: Yvonne P. Bovell            	PHONE NO : 31 30 2297280 
	Professor Bronkhorstlaan 10, build	SE DECISION MADE: 06-DEC-18
	Bilthoven  NL 3723 MB             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Disposable Temperature Probe
	Shenzhen Launch Electrical Co., LT	510(k) NO: K181967(Traditional)
	ATTN: Jiaan  Huang                	PHONE NO : 86 755 29532401 
	No.F Building, Zhonggangxing Indus	SE DECISION MADE: 10-DEC-18
	Shenzhen  CN 518110               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: MectaLIF Posterior Extension
	Medacta International SA          	510(k) NO: K181970(Traditional)
	ATTN: Stefano  Baj                	PHONE NO : 41 91 6966060 
	Strada Regina                     	SE DECISION MADE: 04-DEC-18
	Castel San Pietro  CH CH-6874     	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Acucy Influenza A&B Test with the Acucy System
	Sekisui Diagnostics, LLC          	510(k) NO: K182001(Dual Track)
	ATTN: Shelly  Harris              	PHONE NO : 858 7772627 
	6659 Top Gun St.                  	SE DECISION MADE: 17-DEC-18
	San Diego CA  92121               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths
	Hologic, Inc                      	510(k) NO: K182006(Special)
	ATTN: Rachelle D. Fitzgerald      	PHONE NO : 508 2638631 
	250 Campus Drive                  	SE DECISION MADE: 06-DEC-18
	Marlborough MA  01752             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System
	Renovis Surgical Technologies     	510(k) NO: K182007(Traditional)
	ATTN: Anthony  DeBenedictis       	PHONE NO : 909 5572360 
	1901 W. Lugonia Ave., Suite 340   	SE DECISION MADE: 07-DEC-18
	Redlands CA  92374                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Phasix ST Mesh with Echo 2 Positioning System
	CR Bard Inc.                      	510(k) NO: K182008(Traditional)
	ATTN: Shirin  Mate                	PHONE NO : 401 8258569 
	100 Crossing Boulevard            	SE DECISION MADE: 14-DEC-18
	Warwick RI  02886                 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: ADVIA Centaur Calcitonin (CALCT) assay
	Axis-Shield Diagnostics Limited   	510(k) NO: K182012(Traditional)
	ATTN: Claire  Dora                	PHONE NO : 44 01382 422000 
	Luna Place, The Technology Park   	SE DECISION MADE: 21-DEC-18
	Dundee  GB DD2 1XA                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Simplicit90Y
	Mirada Medical Ltd.               	510(k) NO: K182016(Traditional)
	ATTN: Sarah  Bond                 	PHONE NO : 44 01865 261410 
	Oxford Center for Innovation, New 	SE DECISION MADE: 06-DEC-18
	Oxford  GB ox1 1by                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: SterilContainer S System
	Aesculap, Inc.                    	510(k) NO: K182032(Traditional)
	ATTN: Paul  Amudala               	PHONE NO : 800 2581946 
	3773 Corporate Parkway            	SE DECISION MADE: 21-DEC-18
	Center Valley PA  18034           	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: FFRct
	HeartFlow, Inc                    	510(k) NO: K182035(Special)
	ATTN: Windi  Hary                 	PHONE NO : 650 2411250 
	1400 Seaport Boulevard Building B 	SE DECISION MADE: 06-DEC-18
	Redwood City CA  94063            	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
	YD Diagnostics Corporation        	510(k) NO: K182038(Traditional)
	ATTN: Hyuckjoo  Lee               	PHONE NO : 82 31 3292000 
	76, Seori-ro, Idong-myeon, Cheoin-	SE DECISION MADE: 10-DEC-18
	Yongin-si  KR 17127               	510(k) STATEMENT
	                                                    

DEVICE: Lotus III Multi-Pulsed Er: Yag Laser System
	Laseroptek Co., Ltd.              	510(k) NO: K182045(Third Party - Traditional)
	ATTN: Hong  Chu                   	PHONE NO : 82 31 80235150 
	#116, #117, #203, #204, Hyundai I 	SE DECISION MADE: 27-DEC-18
	Seongnam-Si  KR 13212             	510(k) SUMMARY AVAILABLE FROM FDA
	                                  THIRD PARTY REVIEW

DEVICE: Avenir Complete Hip System
	Zimmer, Inc                       	510(k) NO: K182048(Traditional)
	ATTN: Rebecca D Noftz             	PHONE NO : 574 3732934 
	P.O. Box 708                      	SE DECISION MADE: 07-DEC-18
	Warsaw IN  46581-0708             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: EVOLUX CAD/CAM PMMA BLOCKS
	Blue Dent Dental                  	510(k) NO: K182065(Traditional)
	ATTN: Adriana Paula T I Gomes     	PHONE NO : 55 19 35632222 
	Rua: Joaquim Jorge Port 1272      	SE DECISION MADE: 13-DEC-18
	Pirassununga  BR 13636142         	510(k) STATEMENT
	                                                    

DEVICE: Erran Dental Zirconia
	Hangzhou Erran Technology Co., Ltd	510(k) NO: K182068(Traditional)
	ATTN: Tingkai  Li                 	PHONE NO : 0571 88036310 
	Room F3022, Floor 3, Building 1 (s	SE DECISION MADE: 13-DEC-18
	Hangzhou  CN 310053               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)
	Shenzhen Mindray Bio-medical Elect	510(k) NO: K182075(Traditional)
	ATTN: Yanhong  Bai                	PHONE NO : 86 755 81888998 
	Mindray Building, Keji 12th Road S	SE DECISION MADE: 10-DEC-18
	Shenzhen  TW 518057               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Elekta Unity
	Elekta Limited                    	510(k) NO: K182076(Traditional)
	ATTN: Nicholas  Power             	PHONE NO : 0044 1293 654422 
	Fleming Way                       	SE DECISION MADE: 04-DEC-18
	Crawley  GB RH10 9RR              	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Delta TT Pro
	Limacorporate S.p.A.              	510(k) NO: K182099(Traditional)
	ATTN: Roberto  Gabetta            	PHONE NO : 39 043 2945511 
	via Nazionale 52                  	SE DECISION MADE: 26-DEC-18
	Villanova di San Daniele  IT 33038	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: BA310 Abutment, BIA310 Implant/Abutment
	Cochlear Americas                 	510(k) NO: K182116(Traditional)
	ATTN: Beth  Murray                	PHONE NO : 1 800 5265798 
	13059 E. Peakview Ave.            	SE DECISION MADE: 19-DEC-18
	Centennial CO  80111              	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: EVOLUTION Stemmed CS Femur
	MicroPort Orthopedics Inc.        	510(k) NO: K182125(Traditional)
	ATTN: Hunter Ethan Williams       	PHONE NO : 901 4516511 
	5677 Airline Road                 	SE DECISION MADE: 06-DEC-18
	Arlington TN  38002               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: iSchemaView RAPID
	iSchemaView, Inc.                 	510(k) NO: K182130(Traditional)
	ATTN: Jim  Rosa                   	PHONE NO : 650 3889767 
	201 Marshall Street, Ste. 101     	SE DECISION MADE: 27-DEC-18
	Redwood City CO  94063            	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set
	Sol-Millennium Medical, Inc.      	510(k) NO: K182146(Traditional)
	ATTN: James  Barley               	PHONE NO : 949 4333058 
	1735 North Brown Road, Suite 120  	SE DECISION MADE: 03-DEC-18
	Lawrenceville GA  30043           	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: FFRangio System
	CathWorks Ltd                     	510(k) NO: K182149(Traditional)
	ATTN: Miriam  Ivenshitz           	PHONE NO : 972 97467387 
	3 Rapaport Street                 	SE DECISION MADE: 19-DEC-18
	Kfar-Saba  IL 4465141             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Devon 52 Sequential Compression Device
	Devon Medical Products (Jiangsu) L	510(k) NO: K182150(Special)
	ATTN: Neil  Cheng                 	PHONE NO : 86 513 51080988 
	East Half of 1-2F, Appt D2, 1, Qin	SE DECISION MADE: 18-DEC-18
	Nantong  CN 226017                	510(k) STATEMENT
	                                                    

DEVICE: Powder-Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
	Syntex Healthcare Products Co., Lt	510(k) NO: K182156(Traditional)
	ATTN: Qiao  Zhiqiang              	PHONE NO : 86 311 66179653 
	No. 1, Fanjiazhuang, Industrial Zo	SE DECISION MADE: 10-DEC-18
	Xinji City  CN 052360             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Color Doppler Ultrasound System; Model: mEye1 and mEye2
	Shenzhen Well.D Medical Electronic	510(k) NO: K182165(Traditional)
	ATTN: Ning  Bai                   	PHONE NO : 86 755 36900033 
	Well.d Park, Qinglan 3 Rd, Nationa	SE DECISION MADE: 20-DEC-18
	Shenzhen  CN 518118               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: The ICHOR Panacea Vascular Embolectomy Catheter System
	ICHOR Vascular, Inc.              	510(k) NO: K182167(Traditional)
	ATTN: Jeff  Blair                 	PHONE NO : 651 2104766 
	2865 N Reynolds Rd Suite 220A     	SE DECISION MADE: 21-DEC-18
	Toledo OH  43615                  	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: neoBLUE blanket LED Phototherapy System
	Natus Medical Incorporated        	510(k) NO: K182178(Traditional)
	ATTN: Judy  Buckham               	PHONE NO : 800 4260353 5187
	5900 First Avenue South           	SE DECISION MADE: 13-DEC-18
	Seattle WA  98108                 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A
	Samsung Electronics Co., LTD.     	510(k) NO: K182183(Traditional)
	ATTN: Jaesang  Noh                	PHONE NO : 82 2 21932444 
	129, Samsung-Ro, Yeongtong-Gu     	SE DECISION MADE: 07-DEC-18
	Suwon-Si  KR 16677                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Fetal Doppler
	Shenzhen AOJ Medical Technology Co	510(k) NO: K182190(Traditional)
	ATTN: Qihuan  Zhao                	PHONE NO : 86 18 603031299 
	Room 202, HaoGu Industry Park, 203	SE DECISION MADE: 19-DEC-18
	Shenzhen  CN 518105               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: UV Active Implant System
	DIO Corporation                   	510(k) NO: K182194(Traditional)
	ATTN: Park  Jiae                  	PHONE NO : 82 51 7457836 
	66, Centum Seo-ro, Haeundae-gu    	SE DECISION MADE: 14-DEC-18
	Busan  KR 48058                   	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: TR90BH
	MinXray, Inc                      	510(k) NO: K182207(Traditional)
	ATTN: Keith  Kretchmer            	PHONE NO : 847 5640323 
	3611 Commercial Ave               	SE DECISION MADE: 14-DEC-18
	Northbrook IL  60062              	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: VO200 – NeurOs Cerebral Oximetry System
	Mespere LifeSciences Inc.         	510(k) NO: K182242(Traditional)
	ATTN: Rebecca S. Li               	PHONE NO : 519 8847575 1
	180 Frobisher Drive, Suite 1C     	SE DECISION MADE: 26-DEC-18
	Waterloo  CA N2V 2A2              	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: ARK Tramadol Assay
	ARK Diagnostics, Inc.             	510(k) NO: K182280(Traditional)
	ATTN: Cherry  Mun                 	PHONE NO : 510 2706288 
	48089 Fremont Boulevard           	SE DECISION MADE: 10-DEC-18
	Fremont CA  94538                 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: HyperFil-LV
	Parkell, Inc.                     	510(k) NO: K182296(Traditional)
	ATTN: David  Mott                 	PHONE NO : 631 3891545 
	300 Executive Drive               	SE DECISION MADE: 14-DEC-18
	Edgewood NY  11717                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: BD Contoured Base Pen Needle
	Becton, Dickinson and Company     	510(k) NO: K182320(Traditional)
	ATTN: Meriam  Youssef             	PHONE NO : 201 8476557 
	1 Becton Drive                    	SE DECISION MADE: 20-DEC-18
	Franklin Lakes NJ  07417          	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: LEUCADIA AUTOLOK™ Pedicle Screw System
	ClearView Orthopedic Development, 	510(k) NO: K182339(Special)
	ATTN: Hartmut  Loch               	PHONE NO : 949 7527885 104
	15550-D Rockfield Blvd            	SE DECISION MADE: 12-DEC-18
	Irvine CA  92618                  	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: SafeAir Telescopic Smoke Pencil
	LiNA Medical ApS                  	510(k) NO: K182354(Traditional)
	ATTN: Natalia  Szychulska         	PHONE NO : 48 61 2222121 
	Formervangen 5                    	SE DECISION MADE: 14-DEC-18
	Glostrup  DK 2600                 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: HipCheck
	Stryker Corp.                     	510(k) NO: K182359(Traditional)
	ATTN: Cara  Mellits               	PHONE NO : 408 7542367 
	5900 Optical Ct                   	SE DECISION MADE: 13-DEC-18
	San Jose CA  95138                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Arthrex Compression FT Screws
	Arthrex Inc.                      	510(k) NO: K182361(Traditional)
	ATTN: Rebecca R. Homan            	PHONE NO : 1 239 6435553 73429
	1370 Creekside Boulevard          	SE DECISION MADE: 18-DEC-18
	Naples FL  34108-1945             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Arthrex Compression FT Screws
	Arthrex Inc.                      	510(k) NO: K182361(Traditional)
	ATTN: Rebecca R. Homan            	PHONE NO : 1 239 6435553 73429
	1370 Creekside Boulevard          	SE DECISION MADE: 18-DEC-18
	Naples FL  34108-1945             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Arthrex Compression FT Screws
	Arthrex Inc.                      	510(k) NO: K182361(Traditional)
	ATTN: Rebecca R. Homan            	PHONE NO : 1 239 6435553 73429
	1370 Creekside Boulevard          	SE DECISION MADE: 18-DEC-18
	Naples FL  34108-1945             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: PowerLook Tomo Detection V2 Software
	iCAD Inc.                         	510(k) NO: K182373(Traditional)
	ATTN: John  DeLucia               	PHONE NO : 603 3091945 
	98 Spitbrook Rd. Suite 100        	SE DECISION MADE: 06-DEC-18
	Nashua NH  03062                  	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
	Novo Nordisk Inc.                 	510(k) NO: K182387(Traditional)
	ATTN: Elizabeth  D'Amato          	PHONE NO : 609 9197789 
	800 Scudders Mill Rd              	SE DECISION MADE: 17-DEC-18
	Plainsboro NJ  08536              	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
	Cardiovascular Systems Inc.       	510(k) NO: K182397(Traditional)
	ATTN: Kris  Miller                	PHONE NO : 651 2591656 
	1225 Old Highway 8 NW             	SE DECISION MADE: 13-DEC-18
	St. Paul MN  55112                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: STERRAD VELOCITY Biological Indicator
	Advanced Sterilization Products (A	510(k) NO: K182404(Traditional)
	ATTN: Sun  Choi                   	PHONE NO : 949 4536378 
	33 Technology Drive               	SE DECISION MADE: 27-DEC-18
	Irvine CA  92618                  	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Centricity Universal Viewer
	GE Healthcare                     	510(k) NO: K182419(Traditional)
	ATTN: Renee  Webb                 	PHONE NO : 847 7078783 
	500 West Monroe Street            	SE DECISION MADE: 14-DEC-18
	Chicago IL  60661-3671            	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: ASAHI Corsair Pro XS
	Asahi Intecc Co., Ltd.            	510(k) NO: K182420(Traditional)
	ATTN: Yasuyuki  Kawahara          	PHONE NO : 81 561 485551 
	3-100 Akatsuki-cho                	SE DECISION MADE: 20-DEC-18
	Seto  JP 489-0071                 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Lucitone Denture Base Materials
	Dentsply Sirona                   	510(k) NO: K182422(Traditional)
	ATTN: Karl  Nittinger             	PHONE NO : 717 8494424 
	221 West Philadelphia Street, Suit	SE DECISION MADE: 18-DEC-18
	York PA  17404                    	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: NuFACE FIX Skin Toning Device
	Carol Cole Company dba NuFACE     	510(k) NO: K182424(Traditional)
	ATTN: Donald  Ellis               	PHONE NO : 760 5091264 
	1325 Sycamore Ave. Suite A        	SE DECISION MADE: 18-DEC-18
	Vista CA  92081                   	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
	Shenzhen Caremed Medical Technolog	510(k) NO: K182433(Traditional)
	ATTN: Alan  Xie                   	PHONE NO : 86 755 36560977 889
	East Side, 3/F, C Building, Kelunt	SE DECISION MADE: 17-DEC-18
	Dalang Office, Longhua District, S	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: LaparoGuard
	Mariner Endosurgery Inc.          	510(k) NO: K182434(Traditional)
	ATTN: Mitch  Wilson               	PHONE NO : 1 905 9218755 
	305A, 175 Longwood Road South     	SE DECISION MADE: 13-DEC-18
	Hamilton  CA L8P 0A1              	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Synthetic Polyisoprene Lubricated Male Condom - 5 senses
	Sxwell Usa LLC                    	510(k) NO: K182438(Abbreviated)
	ATTN: Robert  Mahler              	PHONE NO : 732 3452174 
	111 Wood Avenue South             	SE DECISION MADE: 06-DEC-18
	Iselin NJ  08830                  	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: TruShot with Y-Knot All-Suture Anchor
	ConMed Corporation                	510(k) NO: K182446(Special)
	ATTN: Diana L. Nader-Martone      	PHONE NO : 727 3995425 
	525 French Road                   	SE DECISION MADE: 19-DEC-18
	Utica NY  13502                   	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: O2 Concepts Oxlife Independence Model 301-0001
	O2 Concepts LLC                   	510(k) NO: K182454(Third Party - Traditional)
	ATTN: Kathryn G. Forgione         	PHONE NO : 877 8674008 368
	199 Park Road Extension           	SE DECISION MADE: 20-DEC-18
	Middlebury CT  06762              	510(k) SUMMARY AVAILABLE FROM FDA
	                                  THIRD PARTY REVIEW

DEVICE: LATITUDE EV Total Elbow Arthroplasty
	Tornier Inc.                      	510(k) NO: K182461(Traditional)
	ATTN: Renee  Stoffel              	PHONE NO : 952 6837471 
	10801 Nesbitt Ave South           	SE DECISION MADE: 27-DEC-18
	Bloomington MN  55437             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems
	K2M Inc.                          	510(k) NO: K182473(Traditional)
	ATTN: Nancy  Giezen               	PHONE NO : 571 9192000 
	600 Hope Pkwy. SE                 	SE DECISION MADE: 12-DEC-18
	Leesburg VA  20175                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus
	Hycor Biomedical                  	510(k) NO: K182479(Traditional)
	ATTN: Tara  Viviani               	PHONE NO : 714 9333027 
	7272 Chapman Avenue               	SE DECISION MADE: 04-DEC-18
	Garden Grove CA  92841            	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Applanation tonometer AT-2
	Takagi Seiko Co., Ltd.            	510(k) NO: K182491(Traditional)
	ATTN: Shinya  Kitamura            	PHONE NO : 
	330-2                             	SE DECISION MADE: 10-DEC-18
	Nakano-Shi  JP 383-8585           	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: LipiScan Dynamic Meibomian Imager
	TearScience, Inc.                 	510(k) NO: K182506(Traditional)
	ATTN: Christy  Coleman            	PHONE NO : 919 4594815 
	5151 McCrimmon Pkwy. Ste. 250     	SE DECISION MADE: 10-DEC-18
	Morrisville NC  27560             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Route 92 Medical Delivery Catheter
	Route 92 Medical Inc.             	510(k) NO: K182512(Traditional)
	ATTN: Kathy  Tansey               	PHONE NO : 408 3916536 
	1700 S. El Camino Real, Suite 206 	SE DECISION MADE: 10-DEC-18
	San Mateo CA  94402               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: StatStrip Xpress 2 Glucose Hospital Meter System
	Nova Biomedical Corporation       	510(k) NO: K182549(Dual Track)
	ATTN: Khushboo  Surendran         	PHONE NO : 781 8940800 1501
	200 Prospect Street               	SE DECISION MADE: 13-DEC-18
	Waltham MA  02454                 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: StatStrip Xpress Glucose Hospital Meter System
	Nova Biomedical Corporation       	510(k) NO: K182552(Dual Track)
	ATTN: Khushboo  Surendran         	PHONE NO : 781 8940800 1501
	200 Prospect Street               	SE DECISION MADE: 13-DEC-18
	Waltham MA  02454                 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: SureClip Repositionable Hemostasis Clip
	Micro-Tech (Nanjing) CO., Ltd.    	510(k) NO: K182556(Traditional)
	ATTN: Becky  Li                   	PHONE NO : 86 25 58646378 
	NO. 10 Gaoke Third Road           	SE DECISION MADE: 14-DEC-18
	Nanjing  CN 210032                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Quantib ND
	Quantib BV                        	510(k) NO: K182564(Traditional)
	ATTN: Floor van Leeuwen           	PHONE NO : 31 108411749 
	Westblaak 106                     	SE DECISION MADE: 27-DEC-18
	Rotterdam  NL 3012 KM             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Lucent® XP
	Spinal Elements Inc               	510(k) NO: K182584(Traditional)
	ATTN: Cheryl  Allen               	PHONE NO : 760 6071840 
	3115 Melrose Dr., Suite 200       	SE DECISION MADE: 10-DEC-18
	Carlsbad CA  92010                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: KET-1 Blood Ketone Monitoring System
	Apex Biotechnology Corp.          	510(k) NO: K182593(Traditional)
	ATTN: Lisa  Liu                   	PHONE NO : 886 3 5641952 
	No. 7, Li-Hsin Road V, Hsinchu Sci	SE DECISION MADE: 18-DEC-18
	Hsinchu  TW 30078                 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: HERA W10 Diagnostic Ultrasound System
	Samsung Medison Co., Ltd.         	510(k) NO: K182595(Traditional)
	ATTN: Ji Yea Lee                  	PHONE NO : 82 2 21941594 
	3366, Hanseo-ro, Nam-myeon,       	SE DECISION MADE: 18-DEC-18
	Hongcheon-gun  KR 25108           	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Vitrea Software Package, VSTP-001A
	Canon Medical Systems Corporation 	510(k) NO: K182601(Traditional)
	ATTN: Paul  Biggins               	PHONE NO : 81 287 266478 
	1385 Shimoishigami                	SE DECISION MADE: 14-DEC-18
	Otawara  JP 324-8550              	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device
	Medtronic                         	510(k) NO: K182610(Traditional)
	ATTN: Kari  Christianson          	PHONE NO : 763 5149529 
	7611 Northland Drive              	SE DECISION MADE: 19-DEC-18
	Minneapolis MN  55428             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: MIM - MRT Dosimetry
	MIM Software Inc.                 	510(k) NO: K182624(Traditional)
	ATTN: Lynn  Hanigan               	PHONE NO : 216 4550600 
	25800 Science Park Drive - Suite 1	SE DECISION MADE: 18-DEC-18
	Cleveland OH  44122               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: FiXcision
	Agency for Medical Innovations Gmb	510(k) NO: K182664(Traditional)
	ATTN: Martin  Hohlrieder          	PHONE NO : 43 5522 905050 
	Im Letten 1                       	SE DECISION MADE: 07-DEC-18
	Feldkirch  AT 6800                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Rapid Reboot Compression Therapy System
	Rapid Reboot Recovery Products, LL	510(k) NO: K182668(Traditional)
	ATTN: David  Johnson              	PHONE NO : 801 8997511 
	1396 W 200 S Bldg 2A              	SE DECISION MADE: 14-DEC-18
	Lindon UT  84042                  	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute
	Prosidyan, Inc                    	510(k) NO: K182670(Traditional)
	ATTN: Charanpreet S. Bagga        	PHONE NO : 908 5173666 
	41 Spring St, Suite 107           	SE DECISION MADE: 20-DEC-18
	New Providence NJ  07974          	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: KerraContact Ag Perf Advanced Perforated Silver Wound Dressing
	Exciton Technologies, Inc.        	510(k) NO: K182680(Special)
	ATTN: Melanie  Ussyk              	PHONE NO : 780 2485868 
	10230 Jasper avenue, suite 4147   	SE DECISION MADE: 06-DEC-18
	Edmonton  CA T5J 4P6              	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: AC5 Topical Gel
	Arch Therapeutics, Inc.           	510(k) NO: K182681(Traditional)
	ATTN: Terrence W. Norchi          	PHONE NO : 617 4312316 
	235 Walnut Street, Suite 6        	SE DECISION MADE: 14-DEC-18
	Framingham MA  01702              	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: OrthoGold 100
	Tissue Regeneration Technologies  	510(k) NO: K182682(Traditional)
	ATTN: John  Warlick               	PHONE NO : 404 4026844 
	251 Heritage Walk                 	SE DECISION MADE: 21-DEC-18
	Woodstock GA  30188               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: SKR 3000
	KONICA MINOLTA, INC.              	510(k) NO: K182688(Special)
	ATTN: Tsutomu  Fukui              	PHONE NO : 81 42 5898429 
	1 Sakura-machi                    	SE DECISION MADE: 18-DEC-18
	Hino-shi  JP 191-8511             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel
	GenMark Diagnostics, Incorporated 	510(k) NO: K182690(Traditional)
	ATTN: Beth  Stofka                	PHONE NO : 760 5794778 
	5964 La Place Court               	SE DECISION MADE: 21-DEC-18
	Carlsbad CA  92008                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device
	DiaSorin Inc.                     	510(k) NO: K182698(Traditional)
	ATTN: John C. Walter              	PHONE NO : 651 4399710 
	1951 Northwestern Ave.            	SE DECISION MADE: 26-DEC-18
	Stillwater MN  55082-0285         	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Wondfo T-Cup Multi-Drug Urine Test Cup
	Guangzhou Wondfo Biotech Co., Ltd.	510(k) NO: K182701(Traditional)
	ATTN: Bin  Chen                   	PHONE NO : 86 20 32296069 
	No.8 Lizhishan Road, Science City 	SE DECISION MADE: 03-DEC-18
	Guangzhou  CN 510641              	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: One-Step Suprapubic Introducer
	Cook Incorporated                 	510(k) NO: K182709(Traditional)
	ATTN: Carly  Powell               	PHONE NO : 812 3392235 104913
	750 Daniels Way                   	SE DECISION MADE: 26-DEC-18
	Bloomington IN  47404             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: CelerityTM 10 STEAM Chemical Indicator
	STERIS Corporation                	510(k) NO: K182724(Traditional)
	ATTN: Eileen  McCafferty          	PHONE NO : 440 3927189 
	5960 Heisley Rd.                  	SE DECISION MADE: 10-DEC-18
	Mentor OH  44060                  	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: OIC Suture Anchor System
	The Orthopaedic Implant Company   	510(k) NO: K182736(Traditional)
	ATTN: Douglas  Fulton             	PHONE NO : 775 6368281 
	770 Smithridge Dr. #400           	SE DECISION MADE: 28-DEC-18
	Reno NV  89502                    	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: EliA RF IgM Immunoassay
	Phadia AB                         	510(k) NO: K182747(Traditional)
	ATTN: Carina  Magnusson           	PHONE NO : 46 18 165000 
	Rapsgatan 7P                      	SE DECISION MADE: 18-DEC-18
	Uppsala  SE SE 754 50             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: 4D View
	GE Medical Systems Ultrasound and 	510(k) NO: K182750(Traditional)
	ATTN: Tracey  Ortiz               	PHONE NO : 262 4701003 
	9900 W Innovation Drive           	SE DECISION MADE: 21-DEC-18
	Wauwatosa WI  53226               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Disposable Temperature Probe
	Shenzhen Caremed Medical Technolog	510(k) NO: K182755(Traditional)
	ATTN: Alan  Xie                   	PHONE NO : 86 755 36560977 889
	East Side, 3/F, C Building, Kelunt	SE DECISION MADE: 21-DEC-18
	Dalang Office, Longhua District, S	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Neocis Guidance System
	Neocis Inc.                       	510(k) NO: K182776(Special)
	ATTN: Thomas E. Claiborne         	PHONE NO : 631 7938945 
	555 NW 29th ST                    	SE DECISION MADE: 21-DEC-18
	Miami FL  33127                   	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: PTS Professional Chemistry Kit
	Polymer Technology Systems, Inc. d	510(k) NO: K182781(Traditional)
	ATTN: Samuel  Engelman            	PHONE NO : 317 8705610 1009
	7736 Zionsville Road              	SE DECISION MADE: 21-DEC-18
	Indianapolis IN  46268            	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: DePuy Synthes Trauma Orthopedic Nail Implants
	DePuy Synthes                     	510(k) NO: K182783(Traditional)
	ATTN: Elizabeth  Jacobs           	PHONE NO : 610 7195768 
	1301 Goshen Parkway               	SE DECISION MADE: 26-DEC-18
	West Chester PA  19380            	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Cardio-TriTest v6.5
	Cardio-Phoenix Inc.               	510(k) NO: K182790(Special)
	ATTN: Marc  Bisnaire              	PHONE NO : 416 5950795 
	44 Rosemead Close                 	SE DECISION MADE: 14-DEC-18
	Markham  CA L3R 3Z3               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: LENSAR Laser System - fs 3D (LLS-fs 3D)
	Lensar, Inc.                      	510(k) NO: K182795(Traditional)
	ATTN: Keith  Peck                 	PHONE NO : 888 5756412 
	2800 Discovery Drive, Suite 100   	SE DECISION MADE: 21-DEC-18
	Orlando FL  32826                 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: RCT800
	RAY Co., Ltd                      	510(k) NO: K182805(Special)
	ATTN: Changhwan  Lee              	PHONE NO : 82 35 6051000 
	332-7, Samsung 1-ro               	SE DECISION MADE: 14-DEC-18
	Hwaseong-si  KR 18380             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: CUSA Clarity Ultrasonic Surgical Aspirator System
	Integra LifeSciences Corporation  	510(k) NO: K182809(Traditional)
	ATTN: MaryBeth  Carson            	PHONE NO : 609 3737461 
	311 Enterprise Drive              	SE DECISION MADE: 07-DEC-18
	Plainsboro NJ  08536              	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Distal Radius Plating System
	Miami Device Solutions, LLC       	510(k) NO: K182810(Special)
	ATTN: Michelle  Montesino         	PHONE NO : 786 4221400 106
	7620 NW 25th Street, Unit 3 & 4   	SE DECISION MADE: 10-DEC-18
	Miami FL  33122                   	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Medline Cautery Electrode (SILICONE)
	Medline Industries, Inc.          	510(k) NO: K182812(Traditional)
	ATTN: Matt  Clausen               	PHONE NO : 847 6434785 
	Three Lakes Drive                 	SE DECISION MADE: 12-DEC-18
	Northfield IL  60093              	510(k) STATEMENT
	                                                    

DEVICE: SabreLine and SabreGuard Laser Fibers
	Coloplast Corp                    	510(k) NO: K182831(Traditional)
	ATTN: Cori  Ragan                 	PHONE NO : 612 5975106 
	1601 West River Road North        	SE DECISION MADE: 10-DEC-18
	Minneapolis MN  55411             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: minisono
	Alpinion Medical Systems Co., Ltd.	510(k) NO: K182845(Traditional)
	ATTN: Boyeon  CHO                 	PHONE NO : 82 70 74652104 
	5fl, i dong, 77, heungan-daero 81 	SE DECISION MADE: 27-DEC-18
	Anyang-si  KR 14117               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Integra Salto Total Ankle System
	Ascension Orthopedics             	510(k) NO: K182878(Special)
	ATTN: Divya  Savant               	PHONE NO : 609 9366968 
	11101 Metric Blvd.                	SE DECISION MADE: 18-DEC-18
	Austin TX  78758                  	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: 3880 MRI Patient Monitoring System
	Iradimed Corporation              	510(k) NO: K182900(Traditional)
	ATTN: Francis X. Casey            	PHONE NO : 407 6778022 
	1025 Willa Springs Dr             	SE DECISION MADE: 14-DEC-18
	Winter Springs FL  32708          	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Precision1
	Alcon Laboratories, Inc.          	510(k) NO: K182902(Traditional)
	ATTN: Alicia  Plesnarski          	PHONE NO : 678 4153924 
	6201 South Freeway                	SE DECISION MADE: 11-DEC-18
	Fort Worth TX  76134-2099         	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: UniPulse
	Seaward Group                     	510(k) NO: K182905(Traditional)
	ATTN: Jim  Wallace                	PHONE NO : 440 191 5878724 
	15-18 Bracken Hill                	SE DECISION MADE: 14-DEC-18
	Peterlee  GB SR8 2SW              	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: MTS Omadacycline 0.002-32 µg/mL
	Liofilchem s. r. l.               	510(k) NO: K182922(Traditional)
	ATTN: Fabio  Brocco               	PHONE NO : 39 085 8930745 
	Via Scozia zona ind.le            	SE DECISION MADE: 14-DEC-18
	Roseto degli Abruzzi  IT 64026    	510(k) STATEMENT
	                                                    

DEVICE: IntelliSpace Radiology
	Philips Healthcare Informatics, In	510(k) NO: K182926(Third Party - Traditional)
	ATTN: Paige  Gridack              	PHONE NO : 321 3399144 
	4430 Rosewood Drive, Suite 200    	SE DECISION MADE: 06-DEC-18
	Pleasanton CA  94588              	510(k) SUMMARY AVAILABLE FROM FDA
	                                  THIRD PARTY REVIEW

DEVICE: Emission Computed Tomography System
	Shanghai United Imaging Healthcare	510(k) NO: K182938(Traditional)
	ATTN: Shumei  Wang                	PHONE NO : 86 216707 68886776 
	No. 2258 Chengbei Rd., Jiading Ind	SE DECISION MADE: 18-DEC-18
	Shanghai  CN 201807               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Invacare TDX SP2-HD with Captain's Seat
	Invacare Corporation              	510(k) NO: K182946(Special)
	ATTN: Elijah  Wreh                	PHONE NO : 440 3296840 
	One Invacare Way                  	SE DECISION MADE: 11-DEC-18
	Elyria OH  44035                  	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Healix™ Compression Screw System
	Nvision Biomedical Technologies, L	510(k) NO: K182949(Traditional)
	ATTN: Diana  Langham              	PHONE NO : 210 5453713 
	4754 Shavano Oak, Suite 101       	SE DECISION MADE: 04-DEC-18
	San Antonio TX  78249             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Salvo™ Spine System
	Spine Wave, Inc.                  	510(k) NO: K182954(Traditional)
	ATTN: Amy  Noccioli               	PHONE NO : 203 9449494 
	3 Enterprise Drive, Suite 210     	SE DECISION MADE: 12-DEC-18
	Shelton CT  06484                 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Phoenix Atherectomy System
	Volcano AtheroMed Inc.            	510(k) NO: K182972(Special)
	ATTN: Jean  Chang                 	PHONE NO : 650 3525255 
	1530 O'Brien Drive, Suite A       	SE DECISION MADE: 20-DEC-18
	Menlo Park CA  94025              	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: AURORA™ Screw System
	MiRus, LLC                        	510(k) NO: K182989(Traditional)
	ATTN: Jordan  Bauman              	PHONE NO : 678 3246272 
	2150 Newmarket Parkway, Suite 108 	SE DECISION MADE: 18-DEC-18
	Marietta GA  30067                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: enlighten III Laser System
	Cutera, Inc.                      	510(k) NO: K182997(Traditional)
	ATTN: Julia  Brown                	PHONE NO : 415 6575575 
	3240 Bayshore Blvd.               	SE DECISION MADE: 12-DEC-18
	Brisbane CA  94005                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: ViperCath XC Peripheral Exchange Catheter
	Cardiovascular Systems, Inc.      	510(k) NO: K183000(Traditional)
	ATTN: Erika  Huffman              	PHONE NO : 651 2591608 
	1225 Old Highway 8 NW             	SE DECISION MADE: 29-DEC-18
	St. Paul MN  55112                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: EliA SmDP Immunoassay
	Phadia AB                         	510(k) NO: K183007(Traditional)
	ATTN: Carina  Magnusson           	PHONE NO : 46 18 165000 
	Rapsgatan 7P                      	SE DECISION MADE: 24-DEC-18
	Uppsala  SE SE 754 50             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: vascuCAP
	Elucid Bioimaging Inc.            	510(k) NO: K183012(Traditional)
	ATTN: Andrew  Buckler             	PHONE NO : 978 4680508 
	225 Main Street                   	SE DECISION MADE: 21-DEC-18
	Wenham MA  01984                  	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: MOSAIQ Oncology Information System
	Elekta, Inc                       	510(k) NO: K183034(Traditional)
	ATTN: Faiza  Ahmed                	PHONE NO : 408 8308920 
	100 Mathilda Place 5th Floor      	SE DECISION MADE: 04-DEC-18
	Sunnyvale CA  94086               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Dilator Sets
	Cook Incorporated                 	510(k) NO: K183036(Traditional)
	ATTN: David  Lehr                 	PHONE NO : 812 3352235 102309
	750 Daniels Way                   	SE DECISION MADE: 20-DEC-18
	Bloomington IN  47404             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Monaco RTP System
	Elekta, Inc                       	510(k) NO: K183037(Traditional)
	ATTN: Kathryn  Stinson            	PHONE NO : 314 9930003 
	13723 Riverport Drive, Suite 100  	SE DECISION MADE: 04-DEC-18
	Maryland Heights MO  63043        	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Zenition 70
	Philips Medical Systems Nederland 	510(k) NO: K183040(Abbreviated)
	ATTN: Sumit  Kumar                	PHONE NO : 91 702 8039288 
	Veenpluis 4-6                     	SE DECISION MADE: 06-DEC-18
	Best  NL 5684PC                   	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: 3nethra neo
	Forus Health Pvt. Ltd.            	510(k) NO: K183059(Traditional)
	ATTN: Shruti  Kashinath           	PHONE NO : 91 80 41624041 
	#86/2, Ground Floor, Dvg Smaraka B	SE DECISION MADE: 21-DEC-18
	Bengalura  IN 560019              	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Coolrail Linear Pen
	AtriCure, Inc.                    	510(k) NO: K183065(Special)
	ATTN: Caitlin  Wunderlin          	PHONE NO : 513 7554100 
	7555 Innovation Way               	SE DECISION MADE: 04-DEC-18
	Mason OH  45040                   	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Nitrile Glove Powder Free White
	Haining Medical Products Co., Ltd.	510(k) NO: K183068(Traditional)
	ATTN: Zhiming  Yao                	PHONE NO : 86 315 4167693 
	West of Dianchang Road, Luannan Co	SE DECISION MADE: 21-DEC-18
	Tangshan  CN 063500               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: NobelZygoma 0°
	Nobel Biocare AB                  	510(k) NO: K183069(Special)
	ATTN: Charlemagne  Chua           	PHONE NO : 714 2824800 7830
	Box 5190, SE-402 26, Vastra Hamnga	SE DECISION MADE: 04-DEC-18
	Goteborg  SE SE-411 17            	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Mega Plus Spine System
	BK Meditech Co., Ltd              	510(k) NO: K183080(Special)
	ATTN: Meredith Lee May            	PHONE NO : 719 2916874 
	58, Eunhaengnamu-ro Yanggam-myeon 	SE DECISION MADE: 10-DEC-18
	Hwaseong-si  KR 18633             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Senhance Surgical System
	TransEnterix, Inc.                	510(k) NO: K183098(Special)
	ATTN: Michele  Jans               	PHONE NO : 919 7658420 
	635 Davis Drive, Suite 300        	SE DECISION MADE: 06-DEC-18
	Morrisville NC  27560             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra
	Leica Biosystems Newcastle Limited	510(k) NO: K183100(Special)
	ATTN: Jeremy  Allen               	PHONE NO : 0044 191 2154216 
	Balliol Business Park West, Benton	SE DECISION MADE: 07-DEC-18
	Newcastle Upon Tyne  GB NE12 8EW  	510(k) STATEMENT
	                                                    

DEVICE: Zenition 50
	Philips Medical Systems Nederland 	510(k) NO: K183101(Abbreviated)
	ATTN: Sumit  Kumar                	PHONE NO : 91 70 28039288 
	Veenpluis 4-6                     	SE DECISION MADE: 31-DEC-18
	Best  NL 5684PC                   	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody
	Leica Biosystems Newcastle Limited	510(k) NO: K183102(Special)
	ATTN: Jeremy  Allen               	PHONE NO : 0044 191 2154216 
	Balliol Business Park West, Benton	SE DECISION MADE: 07-DEC-18
	Newcastle Upon Tyne  GB NE12 8EW  	510(k) STATEMENT
	                                                    

DEVICE: Intuitive Surgical Vessel Sealer Extend
	Intuitive Surgical, Inc.          	510(k) NO: K183107(Traditional)
	ATTN: Kunal  Gunjal               	PHONE NO : 408 5238017 
	1266 Kifer Road                   	SE DECISION MADE: 11-DEC-18
	Sunnyvale CA  94086               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Contour 24
	Quality Electrodynamics, LLC      	510(k) NO: K183111(Traditional)
	ATTN: Eric  Yeh                   	PHONE NO : 440 4842940 
	6655 Beta Drive Suite 100         	SE DECISION MADE: 07-DEC-18
	Mayfield Village OH  44143        	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: MTS Levofloxacin 0.002 - 32 µg/mL
	Liofilchem s. r. l.               	510(k) NO: K183115(Traditional)
	ATTN: Fabio  Brocco               	PHONE NO : 39 085 8930745 
	Via Scozia zona ind.le            	SE DECISION MADE: 20-DEC-18
	Roseto degli Abruzzi  IT 64026    	510(k) STATEMENT
	                                                    

DEVICE: Unity Network ID
	GE Healthcare                     	510(k) NO: K183116(Special)
	ATTN: Brandon  O'Shea             	PHONE NO : 414 3233147 
	8200 West Tower Ave.              	SE DECISION MADE: 06-DEC-18
	Milwaukee WI  53223               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: microTargeting Guideline 4000 5.0 System
	FHC, Inc.                         	510(k) NO: K183123(Special)
	ATTN: Kelly  Moeykens             	PHONE NO : 207 6665651 
	1201 Main Street                  	SE DECISION MADE: 20-DEC-18
	Bowdoin ME  04287                 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2
	Abbott                            	510(k) NO: K183128(Special)
	ATTN: Cody  Johnson               	PHONE NO : 651 7564217 
	One St. Jude Medical Drive        	SE DECISION MADE: 12-DEC-18
	St. Paul MN  55117                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: IlluminOss Photodynamic Bone Stabilization System
	IlluminOss Medical, Inc.          	510(k) NO: K183145(Special)
	ATTN: Robert  Rabiner             	PHONE NO : 401 7140008 
	993 Waterman Avenue               	SE DECISION MADE: 13-DEC-18
	East Providence RI  02914         	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Affixus Hip Fracture Nail
	Biomet Inc.                       	510(k) NO: K183162(Special)
	ATTN: Dhaval  Saraiya             	PHONE NO : 305 2696386 
	56 East Bell Drive                	SE DECISION MADE: 14-DEC-18
	Warsaw IN  46582                  	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: OpenLoc-L Spinal Fixation System
	L&K Biomed Co., Ltd.              	510(k) NO: K183168(Special)
	ATTN: Jihyeon  Seo                	PHONE NO : 82 2 67171983 
	#201, 202 16-25, Dongbaekjungang-r	SE DECISION MADE: 11-DEC-18
	Yongin-si  KR 17015               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Pulse 2.0, Pulse Pro 2.0
	NormaTec Industries, LP           	510(k) NO: K183169(Third Party - Traditional)
	ATTN: Albert G. Sanford           	PHONE NO : 800 3350960 
	480 Pleasant St, Suite A200       	SE DECISION MADE: 27-DEC-18
	Watertown MA  02472               	510(k) SUMMARY AVAILABLE FROM FDA
	                                  THIRD PARTY REVIEW

DEVICE: Riptide Aspiration System (Riptide Large Bore Aspiration System)
	Micro Therapeutics, Inc. d/b/a ev3	510(k) NO: K183185(Special)
	ATTN: Nancy  Drew                 	PHONE NO : 949 2979563 
	9775 Toledo Way                   	SE DECISION MADE: 18-DEC-18
	Irvine CA  92618                  	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: 6420 Ultrasound System
	Esaote, S.p.A.                    	510(k) NO: K183191(Special)
	ATTN: Massimo  Polignano          	PHONE NO : 39 055 4229402 
	Via enrico Melen 77               	SE DECISION MADE: 04-DEC-18
	Genova  IT 16152                  	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: FlowTriever Retrieval/Aspiration System
	Inari Medical                     	510(k) NO: K183198(Special)
	ATTN: Eben  Gordan                	PHONE NO : 949 6008433 
	9272 Jeronimo Rd., Suite 124      	SE DECISION MADE: 17-DEC-18
	Irvine CA  92618                  	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Nexus DR Digital X-ray Imaging System with stitching
	Varex Imaging Corporation         	510(k) NO: K183212(Special)
	ATTN: Michael Van Ryn             	PHONE NO : 315 2346800 
	121 Metropolitan Drive            	SE DECISION MADE: 07-DEC-18
	Liverpool NY  13088               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
	DiaSorin Molecular LLC            	510(k) NO: K183223(Special)
	ATTN: Sharon  Young               	PHONE NO : 562 2406680 
	11331 Valley View Street          	SE DECISION MADE: 19-DEC-18
	Cypress CA  90630                 	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: CoreLink F3D™ Lateral System
	Corelink, LLC                     	510(k) NO: K183239(Special)
	ATTN: Steven  Mounts              	PHONE NO : 888 3497808 
	2072 Fenton Logistics Blvd.       	SE DECISION MADE: 19-DEC-18
	St. Louis MO  63026               	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: ValPro 2 Plus, VaPro 2 Plus Pocket
	Hollister Incorporated            	510(k) NO: K183253(Special)
	ATTN: Michelle  Schiltz-Taing     	PHONE NO : 847 6802122 
	2000 Hollister Drive              	SE DECISION MADE: 18-DEC-18
	Libertyville IL  60048            	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Selectra Catheters, Selectra Accessory Kit
	Biotronik, Inc.                   	510(k) NO: K183265(Special)
	ATTN: Jon  Brumbaugh              	PHONE NO : 888 3450374 
	6024 Jean Road                    	SE DECISION MADE: 13-DEC-18
	Lake Oswego OR  97035             	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction System
	Osprey Medical, Inc.              	510(k) NO: K183267(Special)
	ATTN: Melanie  Hess               	PHONE NO : 952 9558252 
	5600 Rowland Rd, Suite 250        	SE DECISION MADE: 20-DEC-18
	Minnetonka MN  55343              	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: 17HK701G-W
	LG Electronics Inc.               	510(k) NO: K183286(Traditional)
	ATTN: Jinhwan  Jun                	PHONE NO : 82 31 80665641 
	222, LG-Ro                        	SE DECISION MADE: 07-DEC-18
	Jinwi-Myeon Pyeongtaek-Si  KR 1770	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Magma Spark Pro (Magma Spark Plus, Alpha)
	Formatk Systems Ltd.              	510(k) NO: K183307(Special)
	ATTN: Amit  Goren                 	PHONE NO : 972 4 8571848 
	3 Hayozma St.                     	SE DECISION MADE: 11-DEC-18
	Tirat Hacarmel  IL 3903203        	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: Pulse Rx 2.0, Pulse Pro Rx 2.0
	NormaTec Industries, LP           	510(k) NO: K183328(Third Party - Traditional)
	ATTN: Albert G. Sanford           	PHONE NO : 800 3350960 
	480 Pleasant St, Suite A200       	SE DECISION MADE: 21-DEC-18
	Watertown MA  02472               	510(k) SUMMARY AVAILABLE FROM FDA
	                                  THIRD PARTY REVIEW

DEVICE: Reusable Silicone Cover CPRmeter 2
	Laerdal Medical AS                	510(k) NO: K183348(Special)
	ATTN: Mari  Kaada                 	PHONE NO : 47 51 511700 
	Tanke Svilandsgate 30             	SE DECISION MADE: 17-DEC-18
	Stavanger  NO 2007                	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

DEVICE: COR12 ECG
	Corscience GmbH & Co.             	510(k) NO: K183369(Third Party - Traditional)
	ATTN: Karlheinz  Trost            	PHONE NO : 49 9131 977986 518
	Hartmannstrasse 65                	SE DECISION MADE: 28-DEC-18
	Erlangen  DE D-91052              	510(k) SUMMARY AVAILABLE FROM FDA
	                                  THIRD PARTY REVIEW

DEVICE: ANAX™ OCT Spinal System
	U & I Corporation                 	510(k) NO: K183383(Special)
	ATTN: Young Eun Lee               	PHONE NO : 82 31 8606927 
	20, Sandan-ro 76beon-gil(Rd)      	SE DECISION MADE: 12-DEC-18
	Uijeongbu-si  KR 11781            	510(k) SUMMARY AVAILABLE FROM FDA
	                                                    

Back to Top