14 results · 31ms · Sources: EU EUDAMED, US FDA

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ARTISAN EXTEND CONTROL CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

NA

FDA UDI
aap Implantate AG·04042409089046·APS Lag Screw, self-tapping, TL 22, L 75

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970478·

NA

FDA UDI
aap Implantate AG·04042409089053·APS Lag Screw, self-tapping, TL 22, L 75

BD PYXIS¿ MEDSTATION¿ ES

FDA Adverse Event
Malfunction ·CAREFUSION 303, INC.·Product code BRY·January 23, 2026

DELTA 32; DELTA 32 TACT

FDA 510(k)
FDA Class 2 ·Radiology

THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 26, 2014

MALLORY HEAD PF SOLID RINGLOC ACETABULAR SHELL

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LZO·June 13, 2011

BD PYXIS¿ MEDSTATION¿ ES

FDA Adverse Event
Malfunction ·CAREFUSION 303, INC.·Product code BRY·November 14, 2025

BD PYXIS¿ MEDSTATION¿ 4000

FDA Adverse Event
Malfunction ·CAREFUSION 303, INC.·Product code BRY·September 2, 2025

Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.

FDA Enforcement
Class II ·Terminated·Advanced Sterilization Products·April 10, 2013