18 results · 22ms · Sources: EU EUDAMED, 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