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

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GAP ENDO-EXO MEDULLARY SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526780804·LEVAMED ACTIVE ANKLE SUP SLVR R II

ELMED INCORPORATED

FDA UDI
ELMED INCORPORATED·00198506061141·WALTHER 5 1/4" Catheters For men 32 Fr.

Vatech Clismile

FDA UDI
Rayence Co., Ltd.·08800018601037·This product is an orthodontic bracket and is u...

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0112320·Tap, 4.75mm, Fixed Sleeve

3.2 x 230 mm Surgibit Drill

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215061982·The saleable unit (device count) is 1, there ar...

DELTA CER HEAD 11/13 32MM +6

FDA Adverse Event
Injury ·DEPUY IRELAND - 9616671·Product code LZO·November 15, 2024

CMC CABLE FIX

FDA 510(k)
FDA Class 2 ·Orthopedic

JOINSOON ELECTRONICS MFG CO. LTD HIGH SPEED DIGITAL THERMOMETER, MODEL TC-001

FDA 510(k)
FDA Class 2 ·General Hospital

VIKING

FDA Adverse Event
Death ·LIKO AB·Product code FSA·May 8, 2013

ARCHITECT TOTAL T3

FDA Adverse Event
Malfunction ·A.I.D.D LONGFORD·Product code CDP·September 23, 2014

CAPSUREFIX NOVUS

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 2, 2011

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·November 14, 2025

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

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

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·November 12, 2025

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·February 20, 2026

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

INTROCAN SAFETY® 3

FDA Adverse Event
Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·October 6, 2025

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·August 12, 2016

INTROCAN SAFETY® 3

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·June 25, 2025