21 results · 23ms · Sources: EU EUDAMED, 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