34 results · 23ms · Sources: EU EUDAMED, US FDA

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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