11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KLSA MARTIN HAND DISTRACTOR
FDA 510(k)
FDA Class 2
·Orthopedic
NAMILON POWDER
FDA UDI
AMERICAN TOOTH INDUSTRIES·D772ATI200420660·NAMILON POWDER 16 OZ SHADE 66
C & B FORMULA
FDA UDI
AMERICAN TOOTH INDUSTRIES·D772ATI400420660·C & B FORMULA 1 LB SHADE 66
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FREEZER TEETHER
FDA 510(k)
FDA Class 2
·Dental
TRIAGE CARDIAC PANEL
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code NBC·March 29, 2011
FOLFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·August 27, 2014
VITALITY DS VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
AERO LL FIXATION ANCHOR, 50MM
FDA Adverse Event
Malfunction
·STRYKER SPINE-US·Product code OVD·March 25, 2019
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024