37 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TILOCK PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Oticon
FDA UDI
Oticon A/S·05707131165480·ACTO, ITE VC AP WL R BE
Osstell SmartPeg Type 94
FDA UDI
Osstell AB·09010522002001·ISQ Measurement Peg
DEBAKEY DERRA ANASTOMOSIS CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896003286·DEBAKEY DERRA ANASTOMOSIS CLAMP LARGE CURVED
DEBAKEY DERRA ANASTOMOSIS CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921007570·DEBAKEY DERRA ANASTOMOSIS CLAMP LARGE CURVED
NITANIUM® ARCHWIRE SPRINGS
FDA UDI
Ortho Organizers, Inc.·00190707060541·.012 x .045 Nitanium® Open Coil Spring -15" Spo...
LFIT V40 FEMORAL HEAD COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
FDA 510(k)
FDA Class 1
·General Hospital
UNKNOWN IV CATHETER
FDA Adverse Event
Injury
·BD (SUZHOU)·Product code FOZ·January 13, 2016
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ITI·May 8, 2013
TANDEM T: SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE INC.·Product code LZG·September 12, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 12, 2011
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
FDA Enforcement
Class II
·Ongoing·ROi CPS LLC·September 25, 2024
Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018
TherMax Blood Warmer Unit
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·November 6, 2019
Brilliance iCT - Model 728306 Computed Tomography X-ray systems
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018
IVEA Product Part Number 16100 Model 500A
FDA Enforcement
Class II
·Terminated·Firefly Medical, Inc.·October 11, 2017