13 results
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26ms
·
Sources: EU EUDAMED, US FDA
NEEDLE, BLOOD COLLECTING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690196372·Apex Knee System Common Instruments Pan
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690195078·Apex Knee System Common Instruments Pan Insert
ArgenZ HT+
FDA 510(k)
FDA Class 2
·Dental
VIVID, MODELS 40-A0001, 40-A0004, 40-A0006
FDA 510(k)
FDA Class 1
·Dental
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021
SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·May 5, 2014
ENDOSCOPIC LINEAR CUTTER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 15, 2012
ASR 300 SPIKED CUP SIZE 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 5, 2010
HF-RESECTION ELECTRODE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023
TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·April 25, 2023
HF-RESECTION ELECTRODE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024