8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LCR
FDA 510(k)
FDA Class 2
·Dental
ORTHO-CYCLE CO.
FDA registration
ORTHO-CYCLE CO.·1 product·🇺🇸 United States
DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HORIZONS ERCP CANNULA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PINNACLE MTL INS NEUT36IDX58OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 11, 2013
POST CRANIOTOMY SUBDURAL CATHETER
FDA Adverse Event
Malfunction
·INTEGRA NEURO SCIENCES·Product code GWM·May 22, 2008
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 12, 2011
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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