11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Infrared Thermometer: Model YJ600
FDA 510(k)
FDA Class 2
·General Hospital
Welch Allyn Connex Central Station
FDA 510(k)
FDA Class 2
·Cardiovascular
DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE
FDA 510(k)
FDA Class 2
·Orthopedic
UNKNOWN ACCOLADE STEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·August 25, 2011
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·October 17, 2014
QUARTET
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 18, 2013
LEGION PS OXIN FEM SZ6 LT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·February 19, 2019
GNS II CMT TIB SIZE 5 {} LEFT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·February 19, 2019
LGN PS HIGH FLEX XLPE SZ 5-6 15MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·February 19, 2019
GNS II RESURF PAT 32MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·February 18, 2019
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