9 results · 27ms · Sources: EU EUDAMED, US FDA

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LOW IONIC STRENGTH SOLUTION (LISS)

FDA 510(k)
FDA Class 2 ·Hematology

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690198918·AK3 Congruent Insert Trial Size 1, 13mm

BOSS Instruments

FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515206724·Boss Steinman Pin Smooth, 9", single diamond, r...

MAXIMA V, THREE WHEEL SCOOTER, MODEL SC900V MAXIMA V, FOUR WHEEL SCOOTER, MODEL SC940V

FDA 510(k)
FDA Class 2 ·Physical Medicine

geko T-2 and geko T-3 Neuromuscular Stimulators

FDA 510(k)
FDA Class 2 ·Physical Medicine

UNIFY QUADRA CRT-D

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·May 5, 2014

SPRINT QUATTRO SECURE

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012

CONCERTO II CRT-D

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code NIK·August 10, 2010

Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/50022126-001, 60013879-307, 60013879-407, 60013879-707; CD3211-36/100006984,100012548, 100012550, 100016680, 100031621, 100035618, 100035619, 100042487, 100047194; CD3211-36Q/100004091, 100004093,100019784, 100035620, 100042486, 100047054; CD3215-36/100006995, 100010246, 100010247, 100010249, 100010250, 100012569, 100012570, 100034981, 100046577, 100046802, 60019065; CD3215-36Q/100004059, 100004060, 100004061, 100023304, 100030590, 100033678, 100042492, 100046803, 100046906

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018