21 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
XLIF Decade Plate
FDA UDI
Nuvasive, Inc.·00887517316196·XLIF Decade Plate Guide Pin
Health Support
FDA UDI
Carolon Company·00078301141128·
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321411120·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311411120·
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221036834·Unitek(TM) Bicuspid Band General Purpose Narrow...
3/10 ML BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code MEG·January 17, 2021
RELIANCE SPINAL SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MAGNETOM ESPREE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
22 G X 1 IN. BD ECLIPSE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·February 17, 2016
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 28, 2026
FORTIFY ASSURA VR ICD, US
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code LWS·September 27, 2019
DEPUY ASR XL FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·October 3, 2014
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 27, 2011
BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020