16 results · 23ms · Sources: EU EUDAMED, US FDA

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JO Premium Jelly Original Personal Lubricant

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Novo Surgical

FDA UDI
NOVO SURGICAL, INC.·00842331122200·Titanium Bipolar Bayonet Forceps, (malis type) ...

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690198987·AK3 Congruent Insert Trial Size 2, 14mm

Responsive Orthopedics Total Knee Arthroplasty System

FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973107637·TRIAL 90-SRK-191214 POLY-MPCS 2X14 RIGHT

FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER

FDA 510(k)
FDA Class 2 ·General Hospital

GUARDIAN CONNECTION

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

BD VACUTAINER EDTA 2K

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·January 15, 2021

BD VACUTAINER EDTA 2K

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·February 24, 2021

BD VACUTAINER EDTA 2K

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·July 16, 2021

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 19, 2011

UNKNOWN DEPUY DEVICE

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·June 26, 2013

PROLIEVE THERMODILITATION KIT

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·September 26, 2008

BD TRUCOUNT

FDA Adverse Event
Malfunction ·BD CARIBE, LTD·Product code GKZ·December 15, 2025

ACCESS ACCUTNI REAGENT

FDA Adverse Event
Injury ·BECKMAN COULTER·Product code MMI·September 15, 2016

Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

FDA Enforcement
Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021

dS Breast 7ch 3.0T

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·December 4, 2024