14 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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