22 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PREVENA INCISION MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·July 19, 2019
Bur PM2-95 80K Diam Ø6.0 St
FDA UDI
Bien-Air Surgery SA·17630055514896·
ILIZAROV
FDA UDI
Smith & Nephew, Inc.·03596010029768·4 HOLE PLATE TO HALF RING-THIN
...
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964055683·Endo Carry-On Procedure Kit
V.A.T.S. HARKEN DEBAKEY CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921008210·V.A.T.S. HARKEN DEBAKEY CLAMP WITHOUT RATCHET F...
V.A.T.S. HARKEN DEBAKEY CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896003576·V.A.T.S. HARKEN DEBAKEY CLAMP WITHOUT RATCHET F...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450178218·
Monoblock Tibial Trial UC Insert
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215043216·
N/A
FDA UDI
Doppkon GmbH & Co. KG·04262494463686·Curette forward angled
D 6mm, L 9mm, WL 120mm
ECHOSEED/IODINE-125 SEEDS, MODEL 6733
FDA 510(k)
FDA Class 2
·Radiology
ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY CONFIGURATION, 1 THERAPY CONFIGURATION
FDA 510(k)
FDA Class 2
·General Hospital
Widex
FDA UDI
Widex A/S·05706069722772·Widex CROS-FA BTE (Winter silver SWAP ) Volume ...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 30, 2024
TECNIS ITEC PRELOADED 1-PIECE IOL
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code HQL·May 8, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 12, 2011
DURASEAL DURAL SEALANT SYSTEM
FDA Adverse Event
Injury
·CONFLUENT·Product code NQR·August 6, 2008
COREVALVE TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·August 2, 2018
NEONATAL OXYGEN THERAPY NASAL CANNULA
FDA Adverse Event
Injury
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code CAT·December 16, 2010
CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
FDA Enforcement
Class II
·Terminated·CME America, LLC·December 9, 2020