16 results · 24ms · Sources: EU EUDAMED, US FDA

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OEC Elite MiniView

FDA 510(k)
FDA Class 2 ·Radiology

AED

FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657018852·Hook knife knurled handle

Ophthalmic Ring

FDA UDI
KATENA PRODUCTS, INC.·00841668100745·FLIERINGA RINGS SET OF 8

Ophthalmic Ring

FDA UDI
KATENA PRODUCTS, INC.·00841668100790·FLIERINGA FIXATION RING 18MM

Orbit Depressor

FDA UDI
KATENA PRODUCTS, INC.·00841668100882·SCHEPENS SCLERAL DEPRESSOR SMALL

POINT 500 HD POINT500C HD

FDA 510(k)
FDA Class 2 ·Dental

PHILIPS AVALON FETAL MONITORS FM20 AND FM30

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

INTELLIVUE MULTI-MEASUREMENT MODULE X3

FDA Adverse Event
Malfunction ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·June 12, 2025

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011

UNKNOWN DEPUY FEMORAL HEAD

FDA Adverse Event
Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWY·June 17, 2013

BINAXNOW COVID-19 ANTIGEN SELF TEST

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 15, 2022

INTELLIVUE MULTI-MEASUREMENT MODULE X3

FDA Adverse Event
Malfunction ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·February 11, 2026

RING TRANSJUGULAR INTRAHEPATIC ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·November 15, 2019

Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·April 27, 2016

Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377

FDA Enforcement
Class II ·Completed·Philips North America Llc·September 15, 2021