19 results · 26ms · Sources: EU EUDAMED, US FDA

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LIMACORPORATE SMR REVERSE SHOULDER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Oticon

FDA UDI
Oticon A/S·05707131234995·K50, CIC P 10 BE KIT

N/A

FDA UDI
HANS RUDOLPH, INC.·00874750003235·75 V2 EX SMALL 22ID STR W/HG

Proximity

FDA UDI
ALPHATEC SPINE, INC.·00190376694559·PROXIMITY VA SELF-TAP SCREW, 3.5 x 23mm

Segmental Plating System

FDA UDI
ALPHATEC SPINE, INC.·00190376545486·SPS VA Self-Tap Screw, 3.5 x 23 mm

185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX

FDA 510(k)
FDA Class 2 ·General Hospital

CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013

FDA 510(k)
FDA Class 2 ·General Hospital

REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X30

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·March 10, 2023

HAHN TAPERED IMPLANT Ø5.0 X 8 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 16, 2025

HAHN TAPERED IMPLANT Ø5.0 X 8 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 22, 2025

HAHN TAPERED IMPLANT Ø5.0 X 8 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·April 5, 2024

HAHN TAPERED IMPLANT Ø5.0 X 8 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·January 30, 2024

UNKNOWN DEPUY FEMORAL HEAD

FDA Adverse Event
Injury ·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWY·May 15, 2013

VOCALAID PROFILE TRACHEOSTOMY TUBE

FDA Adverse Event
Malfunction ·MANUFACTURED FOR SMITHS MEDICAL BY: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V·Product code JOH·June 6, 2008

ALIGN TO URETHRAL SUPPORT SYSTEM

FDA Adverse Event
Injury ·C.R. BARD, INC.·Product code FTL·June 1, 2011

REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L30

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·July 21, 2023

BD PYXIS¿ ANESTHESIA STATION ES

FDA Adverse Event
Malfunction ·CAREFUSION 303, INC.·Product code BRY·July 17, 2025

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L131, ESSENTIO DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025