18 results
·
21ms
·
Sources: EU EUDAMED, US FDA
IM-5A INJECTOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780156932·Integra® Jarit® Suction Valve For 600-330 & 630...
3M™ Unitek™ APC™ Clarity™ MBT™
FDA UDI
3M UNITEK CORPORATION·00652221236876·APC FF Clarity Ultra SL MBT U Rt Central 17T/4A...
SuperCable® ISO-Elastic™ Cerclage System
FDA UDI
Kinamed, Inc.·00818720012926·Cable Passer, 60mm, Angled
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, PLASMA SCALPEL GS, C
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HARDY DISK, PENICILLIN, 10 UNITS
FDA 510(k)
FDA Class 2
·Microbiology
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·August 12, 2014
DAMON COPPER NITI WIRE
FDA Adverse Event
Malfunction
·ORMCO CORP.·Product code DZC·February 28, 2008
5.0 CM SHORT ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES PRODUCTS LLC·Product code HBC·January 18, 2019
5.0CM SHORT ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·June 29, 2017
PENUMBRA SMART COIL
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code HCG·February 3, 2017
5.0 CM SHORT ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES PRODUCTS LLC·Product code HBC·January 11, 2019
11.0 CM LONG ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES PRODUCTS LLC·Product code HBC·April 2, 2018
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024