34 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HARDYDISK TICARILLIN 75MCG
FDA 510(k)
FDA Class 2
·Microbiology
Implant Prosthetics
FDA UDI
Preat Corporation·00842092116333·Zimmer® TSV-compatible 3.5mm Straight Multi-Uni...
ESU Shroud
FDA UDI
I.C. MEDICAL, INC.·00817688021940·
QB1 Go System
FDA UDI
Motive Health, Inc.·00854816006714·CyMedica Orthopedics QB1 Go System
Golden Isles Pedicle Screw System
FDA UDI
Intelivation, LLC·G079C2520001750·Curved Ti Rod, 175mm
BR Surgical, LLC
FDA UDI
BR Surgical, LLC·00857556008222·Sinus Scope, autoclavable, Ø 4mm, 0º, 175mm
CNS-9700
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORP.·Product code MHX·December 24, 2014
MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM),
FDA 510(k)
FDA Class 2
·Neurology
RETIC CHEX LINEARITY
FDA 510(k)
FDA Class 2
·Hematology
WALLACH
FDA Adverse Event
Injury
·COOPERSURGICAL, INC.·Product code HGI·March 5, 2026
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·December 23, 2025
LEEP PRECISION GENERATOR
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code HGI·October 13, 2023
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·December 28, 2022
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·July 2, 2025
AL-III W/ MALE DISCONNECT AND 20 FT HOSE
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code GEY·February 14, 2013
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·February 3, 2011
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·February 18, 2008
Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 5, 2014
BrightView XCT (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
BrightView XCT
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 22, 2017