10 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IdentiTi II Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
Medos International Sàrl·10886705029259·ADAPTOR ACMI INSTRUMENT UNIVERSAL TIP
Artman Instruments
FDA UDI
Wise Linkers, LLC·D1272423641·Minnesota Cheek Retractor Gold Plated Surgical ...
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331153587·deschamps ligature carrier, sharp, left, 8" (20...
PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES
FDA 510(k)
FDA Class 2
·Neurology
Barrx RFA Self Sizing Balloon Catheter
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT
FDA Adverse Event
Malfunction
·OBTECH MEDICAL SARL_·Product code LTI·November 11, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 10, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 23, 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