22 results · 22ms · 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.

ABBOTT CARBAMAZEPINE ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

N/A

FDA UDI
TETRA MEDICAL SUPPLY CORP.·00614138127296·BICRO KNEE IMMOBILIZER W/PATELLA STRAP 18" UN

ADVIA Centaur® CA 19-9 MCM

FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414447926·CA19-9 master material - CENTAUR - CONS

SMARTLOCK

FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540492050·LOCKING SCREW, CROSS-PIN

Proximity

FDA UDI
ALPHATEC SPINE, INC.·00190376657141·PROXIMITY VA SELF-DRILL SCREW, 3.5 x 18mm

Complete Cervical

FDA UDI
Seaspine Orthopedics Corporation·10889981040789·Screw - Self-Drilling - 3.5x18mm

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197381550·CERA-CUT® TC Reynolds Scissors curved...

Segmental Plating System

FDA UDI
ALPHATEC SPINE, INC.·00190376536194·SPS VA Self-Drill Screw, 3.5 x 18 mm

Sochi

FDA UDI
Altus Spine, LLC·00843210166476·Polyaxial Screw,3.5mm x 18mm

Atoll™

FDA UDI
Seaspine Orthopedics Corporation·10889981052362·3.5mm x 18mm Poly Screw Assm. The Atoll OCT Spi...

TRINITY ACETABULAR SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ECAT LSO PET/CT 16

FDA 510(k)
FDA Class 2 ·Radiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 20, 2025

VNS PULSE

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·May 9, 2013

INTERMATE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 26, 2014

LIFEVEST WCD 3000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·June 8, 2011

VALEO / VALEO II

FDA Adverse Event
Malfunction ·SINTX TECHNOLOGIES (FORMERLY AMEDICA CORP)·Product code MAX·March 25, 2020

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

ULTRAFLEX DUO HIGH FLUID CART

FDA Adverse Event
Malfunction ·DORNOCH·Product code JCX·August 28, 2017

BARDIA® FOLEY CATHETER SILICONE COATED

FDA Adverse Event
Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code EZC·October 19, 2022