21 results
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26ms
·
Sources: EU EUDAMED, US FDA
INOmax DSIR Plus
FDA 510(k)
FDA Class 2
·Anesthesiology
McKesson
FDA UDI
MCKESSON MEDICAL-SURGICAL INC.·10612479261720·ADULT (PFZ) ANCILLARY 300 DOSE MASTER CONVENIEN...
FANOUS SABERBACK SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896054905·FANOUS SABERBACK SCISSORS CURVED TENOTOMY TIP P...
Olympus
FDA UDI
Gyrus ACMI, LLC·00821925046269·Medical Video Recorder Digital Hub, nCare 4K an...
CUSHING TYING FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896060791·CUSHING TYING FORCEPS TUNGSTEN CARBIDE INSERT P...
HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT
FDA 510(k)
FDA Class 1
·Dental
BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
BIOMEDICS 1 DAY (52%) STRIP (OCUFILCON B)
FDA Adverse Event
Injury
·COOPERVISION CARRIBEAN CORPORATION·Product code MVN·August 29, 2019
DIRECT DRIVE LCA
FDA Adverse Event
Other
·APPLIED MEDICAL RESOURCES·Product code GDO·October 15, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·July 1, 2013
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 13, 2017
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 19, 2017
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
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