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

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PENCAN®

FDA Adverse Event
Injury ·B BRAUN MELSUNGEN AG·Product code BSP·May 6, 2025

PENCAN SPINAL NEEDLE

FDA 510(k)
FDA Class 2 ·Anesthesiology

PENCAN®

FDA Adverse Event
Injury ·B BRAUN MELSUNGEN AG·Product code BSP·April 10, 2025

SOL-M™ Hypodermic Needle

FDA UDI
Sol-Millennium Medical, Inc.·00818392015218·Sterile hypodermic needles intended to inject f...

Biosens cartridges Opaque Pink

FDA UDI
PERFLEX LTD·07290110501655·box of 6 identical cartridges sealed in aluminu...

DD tempMED

FDA UDI
Dental Direkt GmbH·EDDIK112151·DD tempMED are pre-colored dental milling blank...

T-Crystal cartridges Opaque Pink

FDA UDI
PERFLEX LTD·07290110500252·Box of 6 identical cartridges sealed in aluminu...

Disc Prep

FDA UDI
Life Spine, Inc.·00190837089993·

T-Crystal cartridges Opaque Pink

FDA UDI
PERFLEX LTD·07290110506155·5 identical cartridges sealed in a vacuum bag ;...

BIFURCATED VACCINATING NEEDLE

FDA 510(k)
FDA Class 2 ·General Hospital

NP15

FDA 510(k)
FDA Class 2 ·Anesthesiology

Tandry Locking Plate System

FDA UDI
MICROWARE PRECISION CO., LTD.·04719873105892·3.5mm Locking Medial Distal Tibial Plate, 6 Hol...

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·May 14, 2013

TRUWAVE DISPOSABLE PRESSURE TRANSDUCER VAMP COMBO

FDA Adverse Event
Malfunction ·Product code DRS·August 8, 2008

ZOOM CRITICAL CARE BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·May 25, 2011

QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·August 9, 2023

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

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

VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 52/28

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·April 17, 2018

VERSAFITCUP ACETABULAR SHELL CC TRIO Ø 56

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 9, 2018