12 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014606040·SKYTRON 6701/6100 2.25" DELUXE GEL
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450638309·
CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
APC PLUS ADHESIVE
FDA 510(k)
FDA Class 2
·Dental
APC PLUS, CLARITY, MINI UNI-TWIN, VICTORY SERIES
FDA Adverse Event
Injury
·3M UNITEK·Product code DYH·May 9, 2012
REBOUND HRD
FDA Adverse Event
Malfunction
·MINNESOTA MEDICAL DEVELOPMENT, INC.·Product code FTL·May 16, 2011
CORE HEAVY DUTY POWER PACK
FDA Adverse Event
Injury
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·April 26, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 6, 2011
ENDOPATH THOR ENDO LIN CUT THK
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GDW·July 24, 2008
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015