22 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Tyece OTC TENS Model
FDA 510(k)
FDA Class 2
·Neurology
Conventional Lead Apron .5mm Small 22 X 33
FDA UDI
Flow X Ray Corporation·00843696123161·Conventional Lead Apron .5mm Small, Shimmering ...
ULTRA TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DSY·February 27, 2009
FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT (LINED)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES,INC·Product code DSY·February 27, 2009
FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DSY·February 27, 2009
FEMORAL NAIL, A/R T2 FEMUR ? 10X380MM
FDA Adverse Event
Injury
·STRYKER TRAUMA GMBH·Product code HSB·August 3, 2012
SAFIRE BLU, 1304-CPS-7-25-MC-BD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, IRVINE·Product code OAD·August 8, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·October 24, 2014
DRILL, TRI-FLAT T2 FEMUR Ø4,2X340 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS-KIEL·Product code HSZ·July 2, 2013
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·August 19, 2011
PROLENE HERNIA SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·April 1, 2019
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·April 1, 2019
BLAKE DRAIN UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GBX·February 22, 2018
UNKNOWN RIGIDFIX CROSS PIN
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code HTY·July 26, 2019
UNKNOWN BIO-INTRAFIX
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code HWC·July 26, 2019
POWERFLEX P3 PTA DILATATION CATHETER
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code LIT·March 1, 2013
Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number 6290-00-704. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 10, 2014
Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016