21 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EzRay Air Portable (Model: VEX-P300)
FDA 510(k)
FDA Class 2
·Dental
ATLANTIS® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994624994·PLATE 7200182 ATL VISION ELITE 82.5MM
ATLANTIS® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000889630·PLATE 7200182 ATL VISION ELITE 82.5MM
Vilex Jones Fracture Guidewire
FDA UDI
VILEX LLC·00841731123558·Wire, Guide 1.8x200mm Sgl Trocar
MICRO FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896084629·MICRO FORCEPS CURVED TUNGSTEN CARBIDE DUST TIP ...
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114094·SIMCOE CORTEX EXTRACTOR 23GA 0.4MM PK/10
36M - Black & Veach - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588011820·36M - Black & Veach - Metal
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NETILMICIN (0.12-32 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
HARDYDISK TOBRAMYCIN, 10MCG
FDA 510(k)
FDA Class 2
·Microbiology
INFINION 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 8, 2023
UNKNOWN BIGLIANI/FLATOW HUMERAL STEM
FDA Adverse Event
Injury
·ZIMMER INC·Product code KWR·March 11, 2016
UNKNOWN BIGLIANI/FLATOW GLENOID
FDA Adverse Event
Injury
·ZIMMER INC·Product code KWR·March 9, 2016
UNKNOWN BIGLIANI/FLATOW HUMERAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER INC·Product code KWR·March 11, 2016
UNKNOWN BIGLIANI/FLATOW HUMERAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER INC·Product code KWR·March 11, 2016
UNKNOWN BIGLIANI/FLATOW GLENOID
FDA Adverse Event
Injury
·ZIMMER INC·Product code KWR·March 9, 2016
INTERSTIM
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code EZW·October 24, 2014
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·August 10, 2011
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 1, 2013
PHYSICA TT
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code MBH·May 10, 2023
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