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Medical Devices

2007 Device Approvals

The products listed below contain information about what medical uses the device is approved for, when it can be used, and when it should not be used. This information, along with information from your doctor and other sources, can help make you an informed participant in your health care.

Medical Devices Approved by FDA in 2007

2007 Device Approvals

Device NameCategoryDate
ProDisc™-C Total Disc Replacement - P070001 [ARCHIVED] Spinal Disc 12/17/07
Zimmer NexGen® LPS-Flex Mobile and LPS-Mobile Bearing Knees - P060037 [ARCHIVED] Knee Prostheses 12/10/07
ARCHITECT® CORE-M - P060035 [ARCHIVED] Hepatitis Test 11/06/07
Epicel® cultured epidermal autograft (CEA) - H990002 [ARCHIVED] Skin Graft 10/25/07
Exponent® Self-Expanding Carotid Stent with Over-the-Wire (OTW) or Rapid-Exchange (RX) Delivery Systems - P070012 [ARCHIVED] Stent 10/23/07
Mitroflow Aortic Pericardial Heart Valve - P060038 [ARCHIVED] Heart Valve 10/23/07
REALIZE™ Band - P070009 [ARCHIVED] Gastric Band 09/28/07
AMPLATZER® Muscular VSD Occluder - P040040 [ARCHIVED] Heart Occlusion Device 09/07/07
Femoral Introducer Sheath and Hemostasis Device (FISH™) - P050043 [ARCHIVED] Cardiac Catheter 08/20/07
CryoCor Cryoablation - P050024 [ARCHIVED] Ablation Catheter 08/01/07
FLAIR Endovascular Stent Graft - P060002 [ARCHIVED] Stent 07/23/07
GeneSearch™ BLN Test Kit - P060017 [ARCHIVED] Breast Cancer Test 07/16/07
PRESTIGE® Cervical Disc System - P060018 [ARCHIVED] Spinal Disc 07/16/07
VISX STAR S4 IR™ Excimer Laser System with Variable Spot Scanning (VSS™) and WaveScan WaveFront® System - P930016/S25 [ARCHIVED] LASIK 07/11/07
NOVATION™ Ceramic Articulation Hip System - P050039 [ARCHIVED] Hip Prostheses 07/05/07
Cormet Hip Resurfacing System - P050016 [ARCHIVED] Hip Prostheses 07/03/07
Binax Now® Malaria Test - K061542 [ARCHIVED] Malaria Test 06/13/07
INRange Remote Medication Management System - K051338 [ARCHIVED] Medication Management 06/13/07
MONOLISA™ Anti-HBc IgM EIA - P060034 [ARCHIVED] Hepatitis Test 05/31/07
STS-7 Continuous Glucose Monitoring System - P050012/S001 [ARCHIVED] Glucose Monitor 05/31/07
Mynx™ Vascular Closure System - P040044/S001 [ARCHIVED] Vascular Sealant 05/16/07
IMMULITE®/IMMULITE® 1000 and IMMULITE® 2000 Free PSA - P060005 [ARCHIVED] PSA Test 05/11/07
CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System - H060001 [ARCHIVED] Stent 05/08/07
EMS Swiss Dolorclast® - P050004 [ARCHIVED] Shock Wave Therapy 05/08/07
C-flex™ intraocular lens - P060011 [ARCHIVED] Intraocular Lens (IOL) 05/03/07
Perlane® Injectable Gel - P040024/S006 [ARCHIVED] Wrinkle Filler 05/02/07
MONOLISA™ Anti-HBc EIA - P060031 [ARCHIVED] Hepatitis Test 04/27/07
ACUITY™ Steerable Lead Models 4554, 4555, and 4556 - P050046 [ARCHIVED] Pacemaker 04/13/07
Onyx® Liquid Embolic System (Onyx® HD-500) [ARCHIVED] Aneurism Block 04/11/07
IBI Therapy™ Cool Path™ Ablation Catheter and IBI 1500T9 RF Generator - P060019 [ARCHIVED] Ablation Device 03/16/07
INFUSE® Bone Graft - P050053 [ARCHIVED] Dental Graft 03/09/07
Paradigm REAL-Time and Guardian REAL-Time Systems P980022/S015 [ARCHIVED] Glucose Monitor 03/08/07
Histoacryl and Histoacryl Blue - P050013 [ARCHIVED] Skin Adhesive 02/16/07
MESOMARK™ - H060004 [ARCHIVED] Cancer Test 01/24/07
Protégé® GPS™ and Protégé® RX Carotid Stent Systems - P060001 [ARCHIVED] Stent 01/24/07

Page Last Updated: 08/25/2015
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