13 results · 27ms · Sources: EU EUDAMED, 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