12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CAPSTONE CONTROL SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·August 11, 2020
SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone.
FDA Enforcement
Class II
·Terminated·Monteris Medical Corp·November 26, 2014
CoRoent
FDA UDI
Nuvasive, Inc.·00887517574305·CoRoent Ant TLIF Ti, 12x10x36mm 8°
Pediatrics Set LUCY
FDA UDI
Noras MRI products GmbH·04251269206030·The NORAS OR Head Holder LUCY is used for intra...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450192344·
OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT); CATALOG # 0021 (5000 TESTS KIT)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
NON-ABLATIVE WRINKLE TREATMENT HANDPIECE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LUMAX 340 DR-T
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code MRM·May 20, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014
COMPRESS SEGMENTAL ANCHOR PLUG 14MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 10, 2011
MEGA 7.5FR. 40CC
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 10, 2020