11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000
FDA 510(k)
FDA Class 2
·Cardiovascular
Amara
FDA UDI
Respironics, Inc.·00606959009325·
WAVEWRITER ALPHA PRIME 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 24, 2023
UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
0.8% RESOLVE PANEL B FOR GEL
FDA Adverse Event
Malfunction
·ORTHO CLINICAL DIAGNOSTICS·Product code KSZ·May 2, 2013
DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SANTIAGO·Product code KPO·September 15, 2014
MICRO RECIPROCATING SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·April 19, 2011
BD SYRINGE 3ML HEPARIN
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NZW·September 9, 2019
Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09689, Revision A, Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code DQO·October 25, 2010
Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09689, Revision B, Manufacturer: Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code DQO·October 25, 2010