16 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FS ACTIVATOR III
FDA 510(k)
FDA Unclassified
·Unknown
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964022416·The ENDO CARRY-ON Procedure Kit contains all of...
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H65810031851·Ultra Clean L
SCANLAN® Needle Holders
FDA UDI
SCANLAN INTERNATIONAL INC·00846159002898·Jacobson Micro Needle Holder Round Handle
INSET 30
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 30, 2026
GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CPS SHRT LG DRILL GUIDE 5 HOLE
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code FZX·May 23, 2022
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013
D903 DIDECO AVANT
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·February 15, 2011
UNK
FDA Adverse Event
Injury
·UNK·Product code JWH·February 22, 2008
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024