30 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST
FDA 510(k)
FDA Class 2
·Immunology
BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE
FDA Adverse Event
Malfunction
·TAKEDA PHARMACEUTICALS U.S.A., INC.·Product code LHI·May 4, 2026
Sledgehammer
FDA UDI
Keystone Industries·H66810004891·SC 25 lb Pwd & 4 Qt Liq Kit, Original
Implant Prosthetics
FDA UDI
Preat Corporation·00842092116975·NobelBiocare™ Tri-Lobe-compatible NP Multi-Unit...
Affiniti
FDA UDI
TORNIER, INC.·00846832023608·TUBEROSITY REAMER
Implant Prosthetics
FDA UDI
Preat Corporation·00842092133040·NobelBiocare™ Tri-Lobe-compatible NP Multi-Unit...
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167700004890·
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167S1700004890·
PQ1
FDA 510(k)
FDA Class 2
·Dental
SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
4.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM F/IM NAILS-STER
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·September 20, 2013
4.0MM TI LOCKING SCREW W/T25 STARDRIVE 44MM F/IM NAILS-STER
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·September 20, 2013
SCREW,FIXATION,BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·May 18, 2015
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·March 12, 2013
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO·Product code GJS·January 31, 2011
PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·February 21, 2008
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·August 27, 2015
5.0MM TI LOCKING SCREW W/T25 STARDRIVE 56MM FOR IM NAILS
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·April 11, 2018
OMNIPOD 5 CONTROLLER
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·January 30, 2023
BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015