12 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RAPPORT V.T.D.
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
N/A
FDA UDI
Key Scientific Products Incorporated·00850041798028·PEP REAGENT
N/A
FDA UDI
Key Scientific Products Incorporated·00850041798042·Pep ReagentT
CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023
FDA 510(k)
FDA Class 2
·Hematology
Seal Single Use Biopsy Valve
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·January 25, 2013
SIGN SERIES IV STEP SCREW
FDA Adverse Event
Injury
·SURGICAL IMPLANT GENERATION NETWORK (SIGN)·Product code HSB·February 1, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 5, 2014
10MM/130 DEG TI CANN TFNA 360MM/RIGHT - STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·August 3, 2017
SCREWDRIVER BIT AXSOS T15, AO FITTING 4.0MM LOCKING SET
FDA Adverse Event
Malfunction
·STRYKER TRAUMA SELZACH·Product code LXH·June 11, 2014
SCREWDRIVER BIT AXSOS T15, AO FITTING 4.0MM LOCKING SET
FDA Adverse Event
Malfunction
·STRYKER TRAUMA SELZACH·Product code LXH·November 4, 2014
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