8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RIWOLITH 2280 PROBES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCU-CHEK COMPACT TEST STRIP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MA600-IMPEDANCE AUDIOMETER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·January 28, 2013
XIA LP POLYAXIAL SCREW 6.5 X 40MM
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code NKB·November 22, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 14, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015