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