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

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PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ZAVATION ROD CONNECTOR

FDA UDI
Zavation LLC·00197157016142·ROD CONNECTOR, PARALLEL CLOSED 14mm OFFSET, Ø 5...

SCREW,FIXATION,BONE

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code HWC·June 9, 2017

CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL

FDA 510(k)
FDA Class 2 ·Hematology

OPIATES

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

AXON COMPUTER NOTEBOOK

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED, INC·Product code GWF·May 15, 2013

UNKNOWN DEPUY ASR HIP

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 20, 2011

E360 VENTILATOR

FDA Adverse Event
Malfunction ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·August 12, 2008

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES SELZACH·Product code HWC·June 2, 2015

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES SELZACH·Product code HWC·June 3, 2015

Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8151, 2M8151R, 2M8161, 2M8161R

FDA Recall
Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·December 6, 2006

Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8153, 2M8153R, 2M8163, 2M8163R

FDA Recall
Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·December 6, 2006

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

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

Model Number L131, ESSENTIO DR EL MRI Pacemaker

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