11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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X-Twist Biocomposite Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
Sklar®
FDA UDI
SKLAR CORPORATION·10649111352805·SKLARLITEXD CRILE FCP CVD 5.5"
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523184552·R Ultracongruent Tibial Insert Trial Sz C 13mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523184316·R CR E-CIMA Vitamin E Ultracongruent Tibial Ins...
T-WAVE ALTERNANS (TWA) ALGORITHM OPTION
FDA 510(k)
FDA Class 2
·Cardiovascular
Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER
FDA 510(k)
FDA Class 2
·Orthopedic
BD Microtainer SST- Amber Part/Catalog Number: 365978
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·October 16, 2019
GE OEC 9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·November 13, 2008
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code LZG·August 25, 2011
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 18, 2013
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 12, 2014