9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIFEFORCE CLINICAL HYPERBARIC FACILITY
FDA 510(k)
FDA Class 2
·Anesthesiology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192435·Apex Revision Knee Reamer – ZIMMER LONG FLUTES,...
7951125
FDA Adverse Event
Malfunction
·October 10, 2018
AVAflex Vertebral Balloon System
FDA 510(k)
FDA Class 2
·Orthopedic
IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCESS® 2 IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code CDD·February 8, 2013
MULTI-LINK VISION RX
FDA Adverse Event
Injury
·GUIDANT SALES CORPORATION·Product code MAF·December 30, 2010
M2A-38 CUP NON FLARED SZ 56MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 22, 2014
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024