26 results · 21ms · Sources: EU EUDAMED, US FDA

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TRUSIGNAL SPO2 FINGERTIP SENSOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

Endeavour™ MD

FDA UDI
METREX RESEARCH, LLC·00810210820448·Endeavour™ TruColor™ MD headlight system - Nort...

NA

FDA UDI
DEPUY (IRELAND)·10603295001416·FEMORAL HEAD Diameter 28mm +11 14/16 TAPER

HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX

FDA 510(k)
FDA Class 2 ·Hematology

ORTHOVITA PEEK SPACER

FDA 510(k)
FDA Class 2 ·Orthopedic

Widex

FDA UDI
Widex A/S·05706069727173·Widex EVOKE E-PA (Deep Blue S-220 ) RC coil

M2A MAGNUM MODULAR HEAD COCR DIA 44MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·January 6, 2017

LIBERTY CYCLER

FDA Adverse Event
Malfunction ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·May 3, 2013

840 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN·Product code CBK·August 25, 2014

2800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 10, 2011

EVO

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWF·June 27, 2025

DMI Duro-Med Industries Rollator Transport Chair; Wheel Size: 7 1/4"; Overall Width: 23 1/2"; Seat Height: 21 1/4"; Seat Size: 14" x 12 3/4"; Handle Height: 31" - 36"; Width Between Handles: 18"; Weight: 19 Lbs; Walking assistance device.

FDA Enforcement
Class II ·Terminated·Briggs Medical Service Company d.b.a. Mabis·November 5, 2014

MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702

FDA Enforcement
Class II ·Terminated·Ecolab Inc·February 19, 2014

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

Model Number L231, PROPONENT DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

Model Number L211 PROPONENT DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

Model Number U128, VALITUDE CRT-P EL MRI

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

VALITUDE CRT-P pacemaker, Models: a) U125 b) U128

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021