31 results · 23ms · Sources: EU EUDAMED, US FDA

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FDA 510(k)
FDA Class 2 ·Neurology

APEX Revision Knee

FDA UDI
Omni Life Science, Inc.·00841690124474·Modular Offset Stem 15mm x 75mm x 4mm

Trial Cups

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215038984·

COMPACT PLUS - EXTREME - PERFECT PLUS

FDA 510(k)
FDA Class 1 ·Dental

PALLA M SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 3, 2026

Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

FDA Enforcement
Class II ·Ongoing·CORIN MEDICAL, LTD.·July 9, 2025

SYMBIQ 3.13 SINGLE C

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·October 6, 2014

ENRHYTHM MRI

FDA Adverse Event
Injury ·IPG MFG SWITZERLAND·Product code NVZ·June 7, 2013

TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GCJ·June 27, 2011

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·October 7, 2025

ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

FDA Adverse Event
Injury ·COOK INC·Product code FGE·April 25, 2019

ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

FDA Adverse Event
Injury ·COOK INC·Product code FGE·January 4, 2019

ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

FDA Adverse Event
Injury ·COOK INC·Product code FGE·February 18, 2019

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 24, 2026

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 24, 2026

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 24, 2026

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 6, 2026

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 24, 2026

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 24, 2026