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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

MAMMOMAT INSPIRATION PRIME

FDA 510(k)
FDA Class 2 ·Radiology

N/A

FDA UDI
TETRA MEDICAL SUPPLY CORP.·00614138127487·BICRO KNEE IMMOBILIZER W/PATELLA STRAP 20IN UN

Proximity

FDA UDI
ALPHATEC SPINE, INC.·00190376657165·PROXIMITY VA SELF-DRILL SCREW, 3.5 x 20mm

Atoll™

FDA UDI
Seaspine Orthopedics Corporation·10889981052379·3.5mm x 20mm Poly Screw Assm. The Atoll OCT Spi...

Sochi

FDA UDI
Altus Spine, LLC·00843210166483·Polyaxial Screw, 3.5mm x 20mm

Segmental Plating System

FDA UDI
ALPHATEC SPINE, INC.·00190376536217·SPS VA Self-Drill Screw, 3.5 x 20 mm

CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING

FDA 510(k)
FDA Class 2 ·Cardiovascular

SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

EON MINI

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 17, 2013

MINICAP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 26, 2014

SPRINT QUATTRO SECURE

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 14, 2011

BD VACUTAINER® SST¿

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·September 24, 2025

BD VACUTAINER® SST¿

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·September 24, 2025

ARTIS Q ZEEGO

FDA Adverse Event
Malfunction ·SIEMENS HEALTHINEERS AG·Product code OWB·December 10, 2024

TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM

FDA Adverse Event
Malfunction ·CODMAN AND SHURTLEFF, INC·Product code HCG·June 15, 2017

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

BD VACUTAINER® SST¿

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·September 19, 2025

BD VACUTAINER® SST¿

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·December 6, 2024

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

HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.

FDA Enforcement
Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013