14 results
·
18ms
·
Sources: EU EUDAMED, US FDA
HEC 1000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
APC™ II Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221061973·Mini Uni-Twin(TM) Bracket APC(TM) II L4 -11T/0A...
APC™ PLUS Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221092991·Mini Uni-Twin(TM) Bracket APC(TM) PLUS L4 -11T/...
3M™ Unitek™ Uni-Twin™
FDA UDI
3M UNITEK CORPORATION·00652221016065·Mini Uni-Twin(TM) Bracket L4 -11T/0A .018 5/Pk
URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACTICOAT COMPOSITE DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
SHILEY
FDA Adverse Event
Injury
·MALLINCKRODT MEDICAL·Product code JOH·June 3, 2020
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 26, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·February 16, 2011
CYLOS DR - T
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·March 28, 2008
ONYX
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·March 25, 2022
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015