14 results
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17ms
·
Sources: EU EUDAMED, US FDA
VESSEL OCCLUDER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Leica Biosystems
FDA UDI
Leica Biosystems Richmond, Inc.·20849832024792·Apex PT Control Box Slides, Orange
TruLock
FDA UDI
Rmo, Inc.·00885797658289·TRULOCK Light Activated Adhesive Kit (4ea Syrin...
ACCULIF
FDA UDI
Stryker Corporation·07613327105865·INSERTION HANDLE END CAP
BaseVac
FDA UDI
R. E. Morrison Equipment Inc·D13028000740·2SUR4.25-1-3P | 3P 9 User Dual Surgical Vacuum ...
SPECTRUM
FDA UDI
Ortho Arch Company Inc·D9098000741·SPECTRUM ADHESIVE REMOVER
ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX
FDA 510(k)
FDA Class 2
·Dental
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, PLASMA SCALPEL GS, TURBOVAC GS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 8, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·October 12, 2012
FAST-CATH HEMO. INT., 8.5F, SWARTZ SL1, TRANS.
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, AF DIVISION·Product code DYB·August 11, 2010
Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025
Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·November 12, 2014
UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i systems are in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·November 12, 2014