10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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APPLIANCE, FIXATION, SPINAL INTERLAMINAL
FDA Adverse Event
Injury
·SYNTHES USA·Product code KWP·March 31, 2016
Synapse Occipital-Cervical-Thoracic (OCT) System
FDA 510(k)
FDA Class 2
·Orthopedic
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PRODUCTS PALB PERFORMANCE VERIFIERS I & II
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 17, 2024
OCTRODE
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 24, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 30, 2014
ASR UNI FEMORAL IMPL SIZE 41
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 23, 2011
CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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