34 results
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23ms
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Sources: EU EUDAMED, US FDA
BACT/ALERT MB CULTURE BOTTLE
FDA 510(k)
FDA Class 1
·Microbiology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040179406·SUPERFLEX Open Mesh- Double Sided
TEWA
FDA UDI
asia-med GmbH·04251282508203·TeWa CB-Type 2530: coated acupuncture needles ...
TEWA
FDA UDI
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282500887·TeWa CB-Type 2530: coated acupuncture needles ...
Remote Control RF 2100 With Pads
FDA UDI
PARKS MEDICAL ELECTRONICS, INC.·00816787024388·
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·February 24, 2025
Eclipse Pro
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522128714·ECLIPSE PRO,CABLE,PX,3 SNAP,SHORT
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·February 24, 2025
JETLITE 4000
FDA 510(k)
FDA Class 2
·Dental
NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PINNACLE
FDA Adverse Event
Malfunction
·TOLLOS (FORMERLY T.H.E. MEDICAL)·Product code FNG·November 28, 2012
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·March 12, 2013
ANEURX AAADVANTAGE STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·February 18, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LFR·February 15, 2008
TT AUGMENTED 360 BASEPLATE #S-R 15°
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code PHX·January 3, 2024
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
BrightView XCT , Model Number 882482
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 31, 2019
BrightView XCT, Gamma Camera, Product Code 882482
FDA Enforcement
Class II
·Ongoing·Philips North America·January 17, 2024