31 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SIMPLY SPECS
FDA UDI
FGX INTERNATIONAL INC.·00193033440216·
SIMPLY SPECS
FDA UDI
FGX INTERNATIONAL INC.·00193033440223·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112070·Tap, Cannulated, 5.5 mm
SIMPLY SPECS
FDA UDI
FGX INTERNATIONAL INC.·00193033440230·
ARTIFICIAL URINARY SPHINCTER
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code EZY·May 2, 1997
CAMIT DIABETES MANAGEMENT SOFTWARE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55
FDA 510(k)
FDA Class 2
·Orthopedic
ULTRA-THIN SDS BALLOON CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LIT·December 1, 2006
ULTRA-THIN SDS BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORP.·Product code DQY·March 27, 2007
ULTRA-THIN SDS BALLOON CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code DQY·December 28, 2006
ULTRA-THIN SDS BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORP.·Product code DQY·March 5, 2007
ULTRA-THIN SDS BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 28, 2006
ULTRA-THIN SDS BALLOON CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORP.·Product code DQY·April 12, 2007
2520274-2013-01598
FDA Adverse Event
Injury
·SYNTHES (USA) WEST CHESTER, PA·Product code MCV·March 19, 2013
2.3MM 25 DEGREE SHORT BEVEL
FDA Adverse Event
Other
·ARTHROCARE CORP·Product code GEI·February 28, 2011
PUMP MMT-715NAS PRDGM INS V2.1 SK EN
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·March 10, 2008
5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML
FDA Adverse Event
Death
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FOZ·July 12, 2018
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387307, .035/150cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DQX·November 19, 2007
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387312, .035/300cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DQX·November 19, 2007