21 results · 32ms · Sources: EU EUDAMED, US FDA

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HEMOSIL PROTEIN S ACTIVITY ASSAY

FDA 510(k)
FDA Class 2 ·Hematology

REPICCI II RESURFACING KNEE SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304008113·

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112984·CORNEAL TREPHINE BLADE9.5MM

TRIG Reagent Kit

FDA UDI
MEDICA CORPORATION·00386100002121·Triglycerides Reagent Kit for use with EasyRA A...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197116244·Thies Chisel 6 1/4"...

Portex

FDA UDI
ICU MEDICAL, INC.·15019517078787·

MR INSPIRE WITH EXTENDED KIT

FDA 510(k)
FDA Class 2 ·Radiology

'RAPIDONE'-METHADONE TEST

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

VKMO 11000 #QUADROX-I NEO. MIT RESERVOIR

FDA Adverse Event
Injury ·MAQUET CARDIOPULMONARY AG·Product code DTZ·March 27, 2015

QUADROX-I NEO. MIT RESERVOIR

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTN·April 16, 2015

OXYGENATOR, CARDIOPULMONARY BYPASS

FDA Adverse Event
Injury ·MAQUET CARDIOPULMONARY AG·Product code DTZ·April 27, 2015

OXYGENRATOR, CARDIOPULMONARY BYPASS

FDA Adverse Event
Injury ·MAQUET CARDIOPULMONARY AG·Product code DTZ·April 27, 2015

OT VERIO2 METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 4, 2016

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 9, 2013

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 20, 2011

45MM ARTICNG LNR CUTR/6 ROW BL

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDW·August 6, 2008

ARTIC SUN 5000, 115V NA

FDA Adverse Event
Malfunction ·MEDIVANCE, INC. ¿ 1725056·Product code DWJ·September 26, 2017

TRUE METRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·May 8, 2023

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

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