17 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.

HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)

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

ceraMotion®

FDA UDI
DENTAURUM GmbH & Co.KG·J011251082200·ceraMotion® Ti Shoulder B, 20 g / dental cerami...

MicroCross Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED)

FDA 510(k)
FDA Class 1 ·General Hospital

BD INSYTE AUTOGUARD

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY·Product code FOZ·February 20, 2024

BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 12, 2024

I-STAT EC8+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code CHL·September 14, 2021

PARIETEX UGYTEX PP ANTERIOR KIT X1

FDA Adverse Event
Injury ·SOFRADIM PRODUCTION·Product code FTL·September 13, 2011

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·November 14, 2014

ELLIPS FX PHACO HANDPIECE

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code HQC·July 29, 2013

BD INSYTE AUTOG BC

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·July 16, 2024

BD INSYTE AUTOG BC

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·July 16, 2024

BD INSYTE AUTOG BC

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·July 16, 2024

BD INSYTE AUTOG BC

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 12, 2024

CD HORIZON SOLERA 4.75

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code HXX·January 5, 2026

Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·July 10, 2024

Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026