10 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AXSYM BENZODIAZEPINES
FDA 510(k)
FDA Class 2
·Clinical Toxicology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123175·K-WIRE - SINGLE TROCAR THREADED 1.8mm DIA x 150mm
GDC POWER SUPPLY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - FREMONT·Product code HCG·July 20, 2010
OPTIS Integrated System Mobile Workstation
FDA 510(k)
FDA Class 2
·Radiology
ZODIAC SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·December 14, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 8, 2013
R3
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·July 22, 2014
Robotic Pack, part number AMS4389
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
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