13 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRAUMANN GRANULES
FDA 510(k)
FDA Class 2
·Dental
RAPONICEL™
FDA UDI
ADVANCED MEDICAL SOLUTIONS LIMITED·15032749040643·ACTIVHEAL® RAPONICEL™ ULTRA 20X30CM
AT HOME DRUG TEST, MODEL 9083 T
FDA 510(k)
FDA Unclassified
·Unknown
DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CADD
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·March 23, 2022
CADD MEDICATION CASSETTE
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·July 14, 2022
CADD
FDA Adverse Event
Malfunction
·NULL·Product code FPA·August 17, 2021
CADD MEDICATION CASSETTES
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·June 6, 2022
2124215-2013-00788
FDA Adverse Event
Malfunction
·GUIDANT PUERTO RICO BV·Product code NVY·April 8, 2013
VITALITY
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 6, 2011
RSP REVERSE SHOULDER SYSTEM
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWS·May 7, 2008
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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018