7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS
FDA 510(k)
FDA Class 2
·Cardiovascular
LENSTAR, MODEL LS900
FDA 510(k)
FDA Class 2
·Ophthalmic
TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants
FDA 510(k)
FDA Class 2
·Radiology
HEARTSTART XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 13, 2014
EDM LUMBAR DRAINAGE KIT, OPEN TIP CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JXG·February 25, 2013
OT ULTRALINK METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·February 9, 2011
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024