10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Lightin System, Lightin, Lightin Generator
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14ML/I, XPCF-160AML/I
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDCOMP GEN III POWER INJECTABLE PORT
FDA 510(k)
FDA Class 2
·General Hospital
TROCHANTERIC NAIL KIT, TI GAMMA3 10X170MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 14, 2012
MATRIXMANDIBLE DEPTH GAUGE
FDA Adverse Event
Malfunction
·UMKIRK SYNTHES GMBH (DE)·Product code HTJ·December 27, 2021
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011
ONE TOUCH PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·November 4, 2008
DEXTRUS 4137
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·July 17, 2013
ACHIEVE ADVANCE MAPPING CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DRF·August 1, 2023
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