39 results
·
29ms
·
Sources: EU EUDAMED, US FDA
ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
SampLok® Adapter Cap Kit
FDA UDI
ITL ASIA PACIFIC SDN. BHD.·19555240400199·SampLok® Adaptor Cap Kit (SampLok® Adaptor Cap,...
Health Support
FDA UDI
Carolon Company·00078301100743·
Cutimed® Cuticell®
FDA UDI
BSN medical GmbH·04042809809664·CUTIMED CUTICELL STERILE 20CMX40CM 25
Ormco
FDA UDI
ORMCO CORPORATION·00889989027228·SS BROAD ARCH UP SML 0190X0250 PK/10
DEBAKEY THORACIC CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921007040·DEBAKEY THORACIC CLAMP SLIGHT CURVED
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471155868·T Nat D 014 Lo
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756000604·CERV-O-COLLAR
DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DORNIR LC-1 CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197410182·Forceps with oval shaped jaws, heavy
model,...
Young Specialties
FDA UDI
Young Innovations, Inc.·00840326425404·NiTi Thermal Archwire, NAT .014 Lower Dimple 10EA
INTELLIVUE MULTI MEASUREMENT SERVER X2
FDA Adverse Event
Malfunction
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·April 1, 2026
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 8, 2013
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE INC.·Product code LZG·September 12, 2014
TALENT CONVERTER STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·May 18, 2011
COBAS C 501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·May 9, 2022
Ultraview Universal Clinical Workstation Model 90385.
FDA Recall
Terminated
·Spacelabs Medical Inc.·Product code DSI·May 7, 2004
Brilliance iCT Computed Tomography X-ray system, Model 728306
FDA Enforcement
Class III
·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016
Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 30, 2020