10 results
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26ms
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Sources: EU EUDAMED, US FDA
ACKRAD ORAL SUCTION TUBE
FDA 510(k)
FDA Class 1
·Anesthesiology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209128303·
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106594·LESTER FIXATION FORCEPS 2X3 TEETH
MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE
FDA 510(k)TCBS
FDA 510(k)
FDA Class 1
·Microbiology
ISOGELAIR 84 X 35 X 6
FDA Adverse Event
Injury
·STRYKER MEDICAL-KALAMAZOO·Product code FNM·June 6, 2014
WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code ESW·October 5, 2010
PFC*SIGMA C/S NPOR FE LT SZ2.5
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS·Product code JWH·December 3, 2012
Comprehensive Reverse Shoulder System Humeral Tray Model 115340
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·February 22, 2017
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024