16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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