15 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELECTRODE/EXTENSION CABLES, MODELS ATAR
FDA 510(k)
FDA Class 2
·Physical Medicine
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16710709260·
ZEUS-P
FDA UDI
SPINAL ELEMENTS·00840916153199·Zeus-P Trial, 7 x 9 x 26mm
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587P07092670·7mm PLIF Implant 9mm Wide 26mm Length, 7 deg Lo...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1671000709260·
FULL FACE MASK
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code MNT·March 14, 2008
EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
R-SI-LINE METAL-BITE
FDA 510(k)
FDA Class 2
·Dental
GPSIII 30ML PLATELET CONCENTRATION KIT WITH ACD-A
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KSS·August 22, 2018
PINNACLE PELVIC FLOOR REPAIR KITS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 22, 2013
UNKNOWN TRIATHLON PRIMARY TIBIA
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·April 19, 2011
MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES, INC.·Product code LWR·July 8, 2008
RESTORE
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 5, 2013
DEBAKEY, SP, ERG TA
FDA Adverse Event
Injury
·CAREFUSION, INC·Product code GCJ·March 10, 2023
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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