18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUINIDINE ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Reusable Instruments used with SOVEREIGN® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994320674·TRIAL 7964212 S 32X23 12MM 12 DEG
HIGH-PRESSURE CONNECTOR TUBE
FDA 510(k)
FDA Class 2
·Cardiovascular
IL TEST 97573-15, PLASMINOGEN ASSAY
FDA 510(k)
FDA Class 1
·Immunology
PFNA BLADE PERF L100 TAN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HSB·February 15, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·January 19, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 29, 2014
TI MIRS POLYAXIAL SCREW BODY
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code NKB·August 7, 2017
TI MIRS POLYAXIAL SCREW BODY
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code NKB·August 7, 2017
TI MIRS POLYAXIAL SCREW BODY
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code NKB·August 7, 2017
TI MIRS POLYAXIAL SCREW BODY
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code NKB·August 7, 2017
TI MIRS LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code NKB·August 9, 2017
TI MIRS LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code NKB·August 9, 2017
TI MIRS LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code NKB·August 7, 2017
TI MIRS LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code NKB·August 9, 2017
TI MIRS LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code NKB·August 9, 2017
Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy, Model 077 Petite 4"x 17",Model 095: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 095 Large 14" x 27 Model 096: Thermophore Classic, Professional Quality Deep-Heat therapy Model 096, Medium, 14" x 14" Model 097: Thermophore Classic, Professional quality Deep-Heat Therapy, Model 097 , Petite, 4" x 17", Model 255: Thermophore Classic Plus, Professional Quality Deep-Heat Therapy, Model 255 Large,14" x 27", Model 256: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 256, Medium, 14" X 14 Model 277: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 277, Petite , 4" x 17" Used for the temporary relief of joint and muscle pain.
FDA Enforcement
Class II
·Terminated·Battle Creek Equipment Co.·November 9, 2016
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022