Refusal Actions by FDA as Recorded in OASIS
Manufacturer FEI: 3003279193
Manufacturer Name: Amsino Medical Instrument Co Ltd
Manufacturer address line 1: 12 Pu Dong Rd
Manufacturer address line 2:
Manufacturer City: Changchun
Manufacturer Province/state:
Manufacturer Country: China
Product code: 80B--RZ
Importers product description: BLOOD TRANSFUSION SET FOR EXP ONLY
Refusal date: 11-AUG-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: FR1-0012137-0/1/1/
Carrier: SEABOARD MARINE LTD
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
NO REGISTR
Manufacturer FEI: 3006735042
Manufacturer Name: Coviden Lp
Manufacturer address line 1: 15 Hampshire St
Manufacturer address line 2:
Manufacturer City: Mansfield
Manufacturer Province/state: MA
Manufacturer Country: United States
Product code: 80F--MI
Importers product description: NEEDLES FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
Refusal date: 04-AUG-2008
FDA_District: CHI-DO
Entry/doc/line/sfx: 224-0360975-7/1/24/
Carrier: UNITED AIR LINES,INC.
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3007064646
Manufacturer Name: Ningbo Haichuang International Trad
Manufacturer address line 1: 3/F No.16 Bei-Er-Huan-Zhong Road
Manufacturer address line 2:
Manufacturer City: Cixi City, Ningbo
Manufacturer Province/state:
Manufacturer Country: China
Product code: 80F--NK
Importers product description: MEDICAL BED
Refusal date: 20-AUG-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: T94-0049043-7/1/1/
Carrier: CONTINENTAL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
NO 510(K)
Manufacturer FEI: 3002808465
Manufacturer Name: Vygon, S.A.
Manufacturer address line 1: 5-11 Rue Adeline
Manufacturer address line 2:
Manufacturer City: Ecouen
Manufacturer Province/state:
Manufacturer Country: France
Product code: 80F--OS
Importers product description: CATHETERS
Refusal date: 11-AUG-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: K51-0064035-5/1/1/
Carrier: AMERICAN AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002808465
Manufacturer Name: Vygon, S.A.
Manufacturer address line 1: 5-11 Rue Adeline
Manufacturer address line 2:
Manufacturer City: Ecouen
Manufacturer Province/state:
Manufacturer Country: France
Product code: 80F--OS
Importers product description: CATHETERS
Refusal date: 11-AUG-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: K51-0064035-5/2/1/
Carrier: AMERICAN AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002808465
Manufacturer Name: Vygon, S.A.
Manufacturer address line 1: 5-11 Rue Adeline
Manufacturer address line 2:
Manufacturer City: Ecouen
Manufacturer Province/state:
Manufacturer Country: France
Product code: 80F--OS
Importers product description: CATHETERS
Refusal date: 11-AUG-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: K51-0064258-3/1/1/
Carrier: AMERICAN AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002808465
Manufacturer Name: Vygon, S.A.
Manufacturer address line 1: 5-11 Rue Adeline
Manufacturer address line 2:
Manufacturer City: Ecouen
Manufacturer Province/state:
Manufacturer Country: France
Product code: 80F--OS
Importers product description: CATHETERS
Refusal date: 11-AUG-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: K51-0064258-3/4/1/
Carrier: AMERICAN AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002808465
Manufacturer Name: Vygon, S.A.
Manufacturer address line 1: 5-11 Rue Adeline
Manufacturer address line 2:
Manufacturer City: Ecouen
Manufacturer Province/state:
Manufacturer Country: France
Product code: 80F--OS
Importers product description: CATHETERS
Refusal date: 11-AUG-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: K51-0064258-3/5/1/
Carrier: AMERICAN AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 1000165314
Manufacturer Name: Central Admixture Pharmacy Inc.
Manufacturer address line 1: 824 12th Ave
Manufacturer address line 2:
Manufacturer City: Bethlehem
Manufacturer Province/state: PA
Manufacturer Country: United States
Product code: 80F--OZ
Importers product description: IV CATHETER FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
Refusal date: 04-AUG-2008
FDA_District: CHI-DO
Entry/doc/line/sfx: 224-0360975-7/1/12/
Carrier: UNITED AIR LINES,INC.
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
NO 510(K)
Manufacturer FEI: 3003355284
Manufacturer Name: Suzhou Hengxiang Import & Export Co., Ltd.
Manufacturer address line 1: 10F International Economy and Trade
Manufacturer address line 2: Bldg., 6 Xihuan Road
Manufacturer City: Suzhou, Jiangsu
Manufacturer Province/state:
Manufacturer Country: China
Product code: 80F--OZ
Importers product description: CATHETERS/IMPORT FOR EXPORT ONLY/NOT FOR HUMAN USE IN USA
Refusal date: 05-AUG-2008
FDA_District: CHI-DO
Entry/doc/line/sfx: 322-2477482-1/1/1/
Carrier: QANTAS AIRWAYS LIMITED
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
REGISTERED
NO 510(K)
Manufacturer FEI: 3003307657
Manufacturer Name: Ningbo David Medical Device Co.,Ltd
Manufacturer address line 1: No 158 Daqing Rd
Manufacturer address line 2:
Manufacturer City: Shipu Ningbo
Manufacturer Province/state:
Manufacturer Country: China
Product code: 80F--PL
Importers product description: TRANSPORT INCUBATOR
Refusal date: 29-AUG-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: MH9-0069865-4/1/1/
Carrier: CHINA EASTERN AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
NO 510(K)
Manufacturer FEI: 3003286346
Manufacturer Name: Nipro Corporation
Manufacturer address line 1: 3-9-3 Honjo-Nishi
Manufacturer address line 2: Kita-ku
Manufacturer City: Osaka
Manufacturer Province/state:
Manufacturer Country: Japan
Product code: 80F--RN
Importers product description: INFUSION PUMP EXPORT ONLY
Refusal date: 11-AUG-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: FR1-0012158-6/2/1/
Carrier: MITSUI O S K LINES LTD
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3003286346
Manufacturer Name: Nipro Corporation
Manufacturer address line 1: 3-9-3 Honjo-Nishi
Manufacturer address line 2: Kita-ku
Manufacturer City: Osaka
Manufacturer Province/state:
Manufacturer Country: Japan
Product code: 80F--RN
Importers product description: INFUSION PUMP FOR EXPORT ONLY
Refusal date: 25-AUG-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: FR1-0012358-2/3/1/
Carrier: MITSUI O S K LINES LTD
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
NO 510(K)
Manufacturer FEI: 1419843
Manufacturer Name: Armstrong Medical Industries Inc.
Manufacturer address line 1: 575 Knightsbridge Pkwy
Manufacturer address line 2:
Manufacturer City: Lincolnshire
Manufacturer Province/state: IL
Manufacturer Country: United States
Product code: 80J--OK
Importers product description: SCISSORS FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
Refusal date: 04-AUG-2008
FDA_District: CHI-DO
Entry/doc/line/sfx: 224-0360975-7/1/19/
Carrier: UNITED AIR LINES,INC.
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 1000138386
Manufacturer Name: Medline Industries, Inc
Manufacturer address line 1: 9303 Stoneview Dr
Manufacturer address line 2:
Manufacturer City: Dallas
Manufacturer Province/state: TX
Manufacturer Country: United States
Product code: 80K--GX
Importers product description: TAPE FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
Refusal date: 04-AUG-2008
FDA_District: CHI-DO
Entry/doc/line/sfx: 224-0360975-7/1/20/
Carrier: UNITED AIR LINES,INC.
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3005066666
Manufacturer Name: Stewart Medical
Manufacturer address line 1: 2629-C Progressive Way
Manufacturer address line 2:
Manufacturer City: Abbotsford
Manufacturer Province/state:
Manufacturer Country: Canada
Product code: 80K--MI
Importers product description: HEWLETT PACKARD VIRIDIA PATIENT MONITORING SYSTEM
Refusal date: 13-AUG-2008
FDA_District: SEA-DO
Entry/doc/line/sfx: UPS-2058750-5/1/1/
Carrier: UNITED PARCEL SERVICE OF CANA
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
NO 510(K)
Manufacturer FEI: 3001319533
Manufacturer Name: UNKNOWN MANUFACTURER IN MEXICO
Manufacturer address line 1: UNKNOWN MANUFACTURER
Manufacturer address line 2:
Manufacturer City: UNKNOWN
Manufacturer Province/state:
Manufacturer Country: Mexico
Product code: 80L--DQ
Importers product description: Hansaplast Heating Pad
Refusal date: 01-AUG-2008
FDA_District: ATL-DO
Entry/doc/line/sfx: XXX-0149699-2/1/1/
Carrier:
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
NO ENGLISH
Manufacturer FEI: 3006472698
Manufacturer Name: Osiris Inc
Manufacturer address line 1: 2 Finley Rd
Manufacturer address line 2:
Manufacturer City: Brampton
Manufacturer Province/state:
Manufacturer Country: Canada
Product code: 80L--DQ
Importers product description: Kiyoshi Detox Foot Pads
Refusal date: 04-AUG-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: 144-1895416-3/4/1/
Carrier: YORK TRANSPORTATION INC
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): FALSE
Manufacturer FEI: 3004196898
Manufacturer Name: Deer Valley Health Foods
Manufacturer address line 1: 1221 Canyon Meadows Dr Se
Manufacturer address line 2:
Manufacturer City: Calgary
Manufacturer Province/state: ALBERTA
Manufacturer Country: Canada
Product code: 80L--DQ
Importers product description: 858954276080/SYNTHETIC DENTAL MEMBRANE
Refusal date: 21-AUG-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-1559657-1/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3006800291
Manufacturer Name: Scio Norge As
Manufacturer address line 1: Hanoytangen
Manufacturer address line 2:
Manufacturer City: Hauglandshella
Manufacturer Province/state:
Manufacturer Country: Norway
Product code: 80L--DQ
Importers product description: CELL HARMONIZER
Refusal date: 21-AUG-2008
FDA_District: LOS-DO
Entry/doc/line/sfx: BGF-1005126-3/1/1/
Carrier: AIR FRANCE
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
FALSE
REGISTERED
NO 510(K)
Manufacturer FEI: 3007070384
Manufacturer Name: Taylor
Manufacturer address line 1: 306 S Park Ave
Manufacturer address line 2:
Manufacturer City: Winter Park
Manufacturer Province/state: FL
Manufacturer Country: United States
Product code: 80L--DQ
Importers product description: 855303584745 INHALER DEVICE
Refusal date: 25-AUG-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: 112-3999837-3/1/2/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 1713468
Manufacturer Name: ICU Medical (Utah) Inc.
Manufacturer address line 1: 4455 Atherton Dr
Manufacturer address line 2:
Manufacturer City: Salt Lake City
Manufacturer Province/state: UT
Manufacturer Country: United States
Product code: 80L--HI
Importers product description: IV SET FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
Refusal date: 04-AUG-2008
FDA_District: CHI-DO
Entry/doc/line/sfx: 224-0360975-7/1/13/
Carrier: UNITED AIR LINES,INC.
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3002468371
Manufacturer Name: Bard Reynosa S.A. De C.V.
Manufacturer address line 1: Boulevard Montebello 1, Parque
Manufacturer address line 2: Industrial Colonial
Manufacturer City: Reynosa, Tamaulipas
Manufacturer Province/state: Tamaulipas
Manufacturer Country: Mexico
Product code: 80L--JS
Importers product description: POWER PICC SOLO CATHETER 5FR D
Refusal date: 18-AUG-2008
FDA_District: SWI-DO
Entry/doc/line/sfx: UPS-0043304-0/1/12/
Carrier: TRANSPORTES ESPECIALIZADOS DE
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3002468371
Manufacturer Name: Bard Reynosa S.A. De C.V.
Manufacturer address line 1: Boulevard Montebello 1, Parque
Manufacturer address line 2: Industrial Colonial
Manufacturer City: Reynosa, Tamaulipas
Manufacturer Province/state: Tamaulipas
Manufacturer Country: Mexico
Product code: 80L--JS
Importers product description: POWER PICC SOLO CATHETER 6FR T
Refusal date: 18-AUG-2008
FDA_District: SWI-DO
Entry/doc/line/sfx: UPS-0043304-0/1/13/
Carrier: TRANSPORTES ESPECIALIZADOS DE
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3002468371
Manufacturer Name: Bard Reynosa S.A. De C.V.
Manufacturer address line 1: Boulevard Montebello 1, Parque
Manufacturer address line 2: Industrial Colonial
Manufacturer City: Reynosa, Tamaulipas
Manufacturer Province/state: Tamaulipas
Manufacturer Country: Mexico
Product code: 80L--JS
Importers product description: POWER PICC SOLO CATHETER 5FR D
Refusal date: 18-AUG-2008
FDA_District: SWI-DO
Entry/doc/line/sfx: UPS-0043306-5/1/10/
Carrier: TRANS-MEX INC SA DE CV (MX-32
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3002468371
Manufacturer Name: Bard Reynosa S.A. De C.V.
Manufacturer address line 1: Boulevard Montebello 1, Parque
Manufacturer address line 2: Industrial Colonial
Manufacturer City: Reynosa, Tamaulipas
Manufacturer Province/state: Tamaulipas
Manufacturer Country: Mexico
Product code: 80L--JS
Importers product description: POWERPICC SOLO CATHETER PROX V
Refusal date: 18-AUG-2008
FDA_District: SWI-DO
Entry/doc/line/sfx: UPS-0043306-5/1/14/
Carrier: TRANS-MEX INC SA DE CV (MX-32
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 1000138386
Manufacturer Name: Medline Industries, Inc
Manufacturer address line 1: 9303 Stoneview Dr
Manufacturer address line 2:
Manufacturer City: Dallas
Manufacturer Province/state: TX
Manufacturer Country: United States
Product code: 80L--KB
Importers product description: ALCOHOL WIPES FOR MEDICAL KITS FOR INFLIGHT USE ONLY
Refusal date: 04-AUG-2008
FDA_District: CHI-DO
Entry/doc/line/sfx: 224-0360975-7/1/17/
Carrier: UNITED AIR LINES,INC.
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3003338735
Manufacturer Name: JDA Plastic Rubber Co. Ltd.
Manufacturer address line 1: 17 Haibin 7 Road, Tianjin Tree
Manufacturer address line 2: Trade Zone
Manufacturer City: Tianjin
Manufacturer Province/state:
Manufacturer Country: China
Product code: 80L--YY
Importers product description: NITRILE EXAM POWDER FREE EXAM GLOVES IN SMALL,MEDIUM,LARGE,A
Refusal date: 20-AUG-2008
FDA_District: ATL-DO
Entry/doc/line/sfx: 791-5086655-0/1/1/
Carrier: ORIENT OVERSEAS CONTAINER LIN
Bill of Lading:
FDA sample analysis: Yes
FDA record of private lab sample analysis: No
Charge(s): HOLES
Manufacturer FEI: 3007062931
Manufacturer Name: Supermax Gloves
Manufacturer address line 1: Lot 42 Putra
Manufacturer address line 2:
Manufacturer City: Sungai
Manufacturer Province/state:
Manufacturer Country: Malaysia
Product code: 80L--YY
Importers product description: NEW ENGLAND EXAM GLOVES LG- POWDER FREE- NOT FOR RESALE-FOR
Refusal date: 28-AUG-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: BIP-0013426-4/2/1/
Carrier: BWIA INT'L (TRINIDAD AND TOBA
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3007062931
Manufacturer Name: Supermax Gloves
Manufacturer address line 1: Lot 42 Putra
Manufacturer address line 2:
Manufacturer City: Sungai
Manufacturer Province/state:
Manufacturer Country: Malaysia
Product code: 80L--YY
Importers product description: NEW ENGLAND EXAM GLOVES LATEX POWDER- NOT FOR RESALE-FOR EXH
Refusal date: 28-AUG-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: BIP-0013426-4/2/2/
Carrier: BWIA INT'L (TRINIDAD AND TOBA
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3007062931
Manufacturer Name: Supermax Gloves
Manufacturer address line 1: Lot 42 Putra
Manufacturer address line 2:
Manufacturer City: Sungai
Manufacturer Province/state:
Manufacturer Country: Malaysia
Product code: 80L--YY
Importers product description: NEW ENGLAND EXAM GLOVES LATEX LG POWDER FREE-NOT FOR RESALE-
Refusal date: 28-AUG-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: BIP-0013426-4/2/3/
Carrier: BWIA INT'L (TRINIDAD AND TOBA
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3004617435
Manufacturer Name: Zibo Hengchang Plastic & Rubber Products Co., Ltd.
Manufacturer address line 1: Science & Tech. Industrial Park
Manufacturer address line 2: in Zhangdian
Manufacturer City: Zibo City, Shandong Prov.
Manufacturer Province/state:
Manufacturer Country: China
Product code: 80L--YZ
Importers product description: VINYL MEDICAL EXAM GLOVES
Refusal date: 05-AUG-2008
FDA_District: ATL-DO
Entry/doc/line/sfx: 500-3005934-5/1/1/
Carrier: MAERSK SEALAND
Bill of Lading:
FDA sample analysis: Yes
FDA record of private lab sample analysis: No
Charge(s): HOLES
Manufacturer FEI: 3006079422
Manufacturer Name: Wei Fang Jiuzhou Gloves Co.,Ltd.
Manufacturer address line 1: 11 Yangshan Industrial Rd.
Manufacturer address line 2:
Manufacturer City: Shandong
Manufacturer Province/state:
Manufacturer Country: China
Product code: 80L--YZ
Importers product description: POWDER FREE CLEAR VINYL EXAM GLOVES
Refusal date: 19-AUG-2008
FDA_District: CHI-DO
Entry/doc/line/sfx: 525-0746764-6/1/1/
Carrier: CHINA OCEAN SHIPPING COMPANY
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): HOLES
Manufacturer FEI: 3005985328
Manufacturer Name: Liv Medica Equipments Pvt. Ltd.
Manufacturer address line 1: B-26, Phase II, Zone B
Manufacturer address line 2: Tambaram
Manufacturer City: Chennai
Manufacturer Province/state:
Manufacturer Country: India
Product code: 80L--YZ
Importers product description: SURGICAL TYPE GLOVES/SIZE:MEDIUM(PART OF "NEW PARENT FIRST A
Refusal date: 20-AUG-2008
FDA_District: LOS-DO
Entry/doc/line/sfx: MA7-0573786-8/1/2/
Carrier: MITSUI O S K LINES LTD
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: Yes
Charge(s): NO 510(K)
Manufacturer FEI: 3005985328
Manufacturer Name: Liv Medica Equipments Pvt. Ltd.
Manufacturer address line 1: B-26, Phase II, Zone B
Manufacturer address line 2: Tambaram
Manufacturer City: Chennai
Manufacturer Province/state:
Manufacturer Country: India
Product code: 80L--YZ
Importers product description: SURGICAL TYPE GLOVES/SIZE:LARGE(PART OF "NEW PARENT FIRST AI
Refusal date: 20-AUG-2008
FDA_District: LOS-DO
Entry/doc/line/sfx: MA7-0573786-8/1/13/
Carrier: MITSUI O S K LINES LTD
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: Yes
Charge(s): NO 510(K)
Manufacturer FEI: 3005140237
Manufacturer Name: Zibo Henifor Light Industry Pro
Manufacturer address line 1: Co Ltd
Manufacturer address line 2:
Manufacturer City: Zibozibo
Manufacturer Province/state:
Manufacturer Country: China
Product code: 80L--YZ
Importers product description: GLOVE, PATIENT EXAMINATION, VINYL;;
Refusal date: 29-AUG-2008
FDA_District: NWE-DO
Entry/doc/line/sfx: 855-0022039-8/1/1/
Carrier: CHINA OCEAN SHIPPING COMPANY
Bill of Lading:
FDA sample analysis: Yes
FDA record of private lab sample analysis: No
Charge(s): HOLES
Manufacturer FEI: 1000138386
Manufacturer Name: Medline Industries, Inc
Manufacturer address line 1: 9303 Stoneview Dr
Manufacturer address line 2:
Manufacturer City: Dallas
Manufacturer Province/state: TX
Manufacturer Country: United States
Product code: 80L--ZC
Importers product description: NITRILE GLOVES FOR UAL MEDICL KIT FOR INFLIGHT USE ONLY
Refusal date: 04-AUG-2008
FDA_District: CHI-DO
Entry/doc/line/sfx: 224-0360975-7/1/18/
Carrier: UNITED AIR LINES,INC.
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
NO 510(K)
Manufacturer FEI: 3007029364
Manufacturer Name: Sercon Industria & Comercio De Aparelhos Medico
Manufacturer address line 1: Rua Tenente Onofre Rodrigues De Aguiar
Manufacturer address line 2:
Manufacturer City: Mogi Das Cruzes
Manufacturer Province/state:
Manufacturer Country: Brazil
Product code: 80M--ED
Importers product description: STERILIZER
Refusal date: 29-AUG-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: MH9-0069589-0/1/1/
Carrier: ALIANCA NAVEGACAO & LOGISTICA
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
NO 510(K)
Manufacturer FEI: 3006995909
Manufacturer Name: Kingfox Enterprises Limited
Manufacturer address line 1: Room 60 Building 5 Benghe Road
Manufacturer address line 2:
Manufacturer City: Futian Shezhen
Manufacturer Province/state:
Manufacturer Country: China
Product code: 80M--SN
Importers product description: LUNG CARE APPARATUS (MEDICAL EQUIPMENT)
Refusal date: 27-AUG-2008
FDA_District: LOS-DO
Entry/doc/line/sfx: 700-0120511-4/1/1/
Carrier: AMERICAN AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
NO 510(K)
Manufacturer FEI: 3002808465
Manufacturer Name: Vygon, S.A.
Manufacturer address line 1: 5-11 Rue Adeline
Manufacturer address line 2:
Manufacturer City: Ecouen
Manufacturer Province/state:
Manufacturer Country: France
Product code: 80M--WV
Importers product description: NEEDLES
Refusal date: 11-AUG-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: K51-0064035-5/4/1/
Carrier: AMERICAN AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3005825381
Manufacturer Name: Terumo
Manufacturer address line 1: Nv 3001
Manufacturer address line 2:
Manufacturer City: Leuven
Manufacturer Province/state:
Manufacturer Country: Belgium
Product code: 80M--WV
Importers product description: 958087650779 HYPODERMIC NEEDLE
Refusal date: 22-AUG-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-1577726-2/2/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): RX DEVICE
NOT LISTED