9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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xvision Spine system (XVS)
FDA 510(k)
FDA Class 2
·Neurology
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551112051·HALO, 1203-5 VEST MEDIUM, ACRYLIC LINER, 1211-1...
COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GE LOGIQ 9, MODEL 2188900-X
FDA 510(k)
FDA Class 2
·Radiology
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 20, 2016
SMALLBORE Y-EXTENSION SET
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL, INC.·Product code FPA·October 10, 2008
CAPTURE-R READY SCREEN I AND II
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·August 15, 2011
SOLETRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 8, 2013
StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
FDA Enforcement
Class II
·Ongoing·Stimwave Technologies Inc·September 9, 2020