12 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
E320 OTP Delivery System
FDA UDI
Engle Dental Systems, LLC·00850043433262·Utility Center Mounted Dr. & Asst E300 Delivery...
TraXis®
FDA UDI
ZIMMER SPINE, INC.·00889024332829·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16710030709250·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197541329·Ferreira Style Breast Retractor
70x25m...
SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E
FDA 510(k)
FDA Class 2
·Anesthesiology
CARBODISSECTING ENDOSCOPE
FDA 510(k)
FDA Class 2
·Cardiovascular
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 16, 2026
UNKNOWN TRIATHLON PRIMARY FEMUR
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·April 19, 2011
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·April 22, 2013
MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES, INC.·Product code LWR·July 8, 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