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

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Insulin Syringe

FDA 510(k)
FDA Class 2 ·General Hospital

EVONOS

FDA UDI
Gyrus ACMI, LLC·00821925019423·EAR SURGERY SCISSORS-STRAIGHT

Cooley Ring-Bulldog Clamp 12,5cm

FDA UDI
Geister Medizintechnik GmbH·04057034060841·Cooley Ring-Bulldog Clamp 12,5cm

Intrigue

FDA UDI
LANCER ORTHODONTICS, INC.·00817573020157·INTRG WHISP-Z ROTH 1BICHK -17T 0A 018 LR

Flexible Driver

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215067779·

PS 3000 DIGATAL PHOTOSPOT SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

PICCOLO COMPOSITE PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MPACT ACETABULAR SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·January 23, 2026

RESERVOIR 3ML

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 11, 2014

OT ULTRA EASY METER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·August 31, 2011

ACCU-CHEK ® COMPACT PLUS

FDA Adverse Event
Injury ·ROCHE DIAGNOSTICS·Product code NBW·July 16, 2013

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 13, 2024

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 13, 2025

MPACT ACETABULAR SYSTEM IMPLANTS

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LPH·November 5, 2025

MPACT ACETABULAR SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 18, 2025

bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Recall
Open, Classified ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 27, 2025

AMISTEM-P COLLARED

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 14, 2025

MPACT ACETABULAR SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·February 6, 2026

bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025