11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Nitrile Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
Pressure Sentinel®
FDA UDI
Zimmer, Inc.·00889024038875·
Pressure Sentinel®
FDA UDI
Zimmer, Inc.·00889024038882·
HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
STEERABLE GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 5H/RT/94MM
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HRS·January 9, 2015
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·August 25, 2011
TRILOGY 202
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·August 6, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 12, 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
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018