10 results
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34ms
·
Sources: EU EUDAMED, US FDA
SPINAL WRENCH
FDA 510(k)
FDA Class 1
·Orthopedic
Sphero Attachments
FDA UDI
Preat Corporation·00842092121986·Sphero Block Abutment Nobel Active NP x 7mm (2....
Bioplate®
FDA UDI
Bioplate, Inc.·M3848130670·Drill Bit, 1.2mm diam., 4.5mm
Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
FRIALOC DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 15, 2014
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·October 31, 2012
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·August 15, 2010
EXTERNAL NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·June 22, 2020
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018