39 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
Prep Kit - Midmark IQholter, 7-lead
FDA UDI
MIDMARK CORPORATION·00841709100703·These kits are designed to provide the supplies...
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981172626·Axial, Closed, 90mm
MD-Max ULIF
FDA UDI
PRECISION SPINE, INC.·00840019925990·Medial Retractor Blade, 90 mm
Golden Isles Pedicle Screw System
FDA UDI
Intelivation, LLC·G079C2520000900·Curved Titanium Rod
TAURUS
FDA UDI
CTL Medical Corporation·00841732150751·5.5mm Curved Rod 90mm Ti Alloy
Lattus
FDA UDI
Seaspine Orthopedics Corporation·10889981307660·Cephalad/Caudal 90mm Blade, AL
Lattus
FDA UDI
Seaspine Orthopedics Corporation·10889981307561·Posterior Blade, SS, 90mm
THORATEC® PVAD™, RVAD ELECTRICAL EXTENSION LEAD 7FT
FDA UDI
Thoratec Corporation·00813024012689·
Preference 2
FDA UDI
SINTX Technologies, Inc.·M555102000090·Curved Rod 6.0mm, 90mm
Taurus Pedicle Screw System
FDA UDI
SINTX Technologies, Inc.·M555252000090·Taurus Pedicle Screw System-Curved Rod 5.5x90mm
MODIFICATION TO ISOBAR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SPIRAL RADIUS RODDING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TEGO¿ CONNECTOR
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·November 14, 2024
PFC SIGMARP CV TB/IN S5 10.0
FDA Adverse Event
Injury
·DEPUY IRELAND·Product code NJL·March 12, 2013
M-1 COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·February 18, 2011
PFC SIGMARP STB TB IN 4 10.0
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code NJL·February 18, 2008
STYLE 15 SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·May 28, 2025
TEGO¿ CONNECTOR
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·January 9, 2025
Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015