21 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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HS40 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
StarDental Instrument Solutions
FDA UDI
DENTALEZ, INC.·D7022003390·CLASSIQUE DIA INSTRUMENTS 701-10P
INBONE
FDA UDI
WRIGHT MEDICAL TECHNOLOGY, INC.·00840420196330·Square Drive
ELMED
FDA UDI
ELMED INCORPORATED·00198506056994·LUBRICATION OIL FOR SURGICAL INSTRUMENTS, 10/PK...
DXTEND SCREW LOCK D4.5X36MM
FDA Adverse Event
Injury
·DEPUY FRANCE SAS - 3003895575·Product code HSD·June 11, 2018
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·February 1, 2022
VICTORY XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·October 24, 2014
ARMADA 14 PTA CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LIT·August 11, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·July 1, 2013
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·September 25, 2024
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·July 13, 2023
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·May 23, 2024
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·June 7, 2024
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·November 28, 2024
SUPER SHEATH
FDA Adverse Event
Injury
·TOGO MEDIKIT CO., LTD.·Product code DRE·October 31, 2023
StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.
FDA Enforcement
Class II
·Terminated·Dental EZ Stardental Division·June 19, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
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