10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W
FDA 510(k)
FDA Class 2
·Cardiovascular
QUICKANCHOR ORTHOCORD
FDA UDI
DEPUY MITEK, LLC·10886705008575·Rotator Cuff QUICKANCHOR Plus DS With two Numbe...
VIDAS LYME IGM
FDA 510(k)
FDA Class 2
·Microbiology
LAPARETTE, MODEL LAP J L S H N
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER - INTERNATIONAL KIT
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code GCJ·September 13, 2024
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·August 10, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 6, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 12, 2013
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025