13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SAHARA Stabilization System
FDA 510(k)
FDA Class 2
·Orthopedic
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668101100·HELVESTON "GREAT BIG BARBIE" RETRACTOR 11MM
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306812170·Graefe (Iris ) Single, Delicate, Flat Handle , ...
HIP END EFFECTOR- VARIABLE ANGLE
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·April 9, 2015
INCONTROL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPAPLUS
FDA 510(k)
FDA Class 2
·Immunology
MONACO
FDA Adverse Event
Malfunction
·ELEKTA INC.·Product code MUJ·July 28, 2021
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·January 24, 2011
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·June 10, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
PRIME CARE (R) TRANSCEND MATTRESS
FDA Adverse Event
Malfunction
·PRIMUS MEDICAL LLC·Product code IKY·September 18, 2014
MONACO
FDA Adverse Event
Malfunction
·ELEKTA INC·Product code MUJ·August 25, 2021
Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024