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