21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777594·LUMBAMED BASIC DORSAL STAY WM SILVER II
StaClear Syringe
FDA 510(k)
FDA Class 2
·General Hospital
MICRO TYING FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896084711·MICRO TYING FORCEPS WITH PLATFORM STRAIGHT TUNG...
Drill Guide
FDA UDI
Treace Medical Concepts, Inc.·00810111223591·Drill Guide - 15.5MM
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114223·LASIK CANNULA FLATTENED 25GA
SCANLAN®
FDA UDI
SCANLAN INTERNATIONAL INC·00846159007558·Lambert-Kay Anastomosis Clamp
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319742488·Dunning Elevator and Curette 8-1/4" (20.6cm), b...
Stealth Abutment
FDA UDI
BICON, LLC·00813110021328·5.0 x 6.0mm 10° Stealth Abutment - 2.0mm Post
ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE
FDA 510(k)
FDA Class 2
·Orthopedic
EMULATE FAST SET AND EMULATE REGULAR SET
FDA 510(k)
FDA Class 2
·Dental
FUSION QUATTRO EXTRACTION BALLOON
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code GCA·December 10, 2024
RS GLENOID PLATE EXT CAG +10MM CAGE PEG
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·July 17, 2023
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·August 11, 2011
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·October 22, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·July 1, 2013
ACESSA PROVU HANDPIECE
FDA Adverse Event
Injury
·ACESSA HEALTH INC.·Product code HFG·November 8, 2021
FUSION QUATTRO EXTRACTION BALLOON
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code GCA·June 7, 2024
Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and LikoGuard L and XL.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·November 9, 2016
Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and LikoGuard L and XL.
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code FSA·August 9, 2016
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014