20 results · 21ms · Sources: EU EUDAMED, US FDA

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DEPUY STTUNE (TM) PS KNEE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

NA

FDA UDI
Smith & Nephew, Inc.·03596010038883·DISPOSABLE ACETABULUM CEMENT ...

ARGENCO 883KF

FDA UDI
ARGEN CORPORATION, THE·D818111433·Gold based noble metal

Orthoquest

FDA UDI
Young Innovations, Inc.·00843471156254·Cutanium 27° D-Form 016X025

MicroSelectron Digital

FDA UDI
Nucletron B.V.·08717213032644·microSelectron Coupling Transfer Tube (13)

DEPUY ATTUNE KNEE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

BALLERT CRANIAL MOLDING HELMET

FDA 510(k)
FDA Class 2 ·Neurology

PRONTO SPOT CHECK PULSE CO-OXIMETER

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 9, 2018

BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·June 6, 2022

BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BD SUZHOU·Product code FOZ·August 16, 2022

CAREASSIST BED

FDA Adverse Event
Malfunction ·HILLROM DE MEXICO S DE RL DE CV·Product code FNL·April 23, 2013

BALL HEX SCREWDRIVER 8MM FOR TI FEMORAL NAILS

FDA Adverse Event
Malfunction ·SYNTHES BRANDYWINE·Product code HXX·September 23, 2014

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·June 2, 2011

BD INTIMA II PLUS¿ IV CATHETER

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·October 20, 2022

BD INTIMA II PLUS¿ IV CATHETER

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·October 20, 2022

ACCESS® 2 IMMUNOASSAY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JJE·October 6, 2011

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 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