16 results
·
33ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112922·CORNEAL TREPHINE BLADE7.75MM
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112502·BARRON VACUUM TREPHINE 7.75MM
SprintRay Apex Teeth - A1 - 500 g
FDA UDI
Sprintray, Inc.·00850039704697·APEX Teeth is a light-curable polymerizable res...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112762·BARRON VACUUM PUNCH 7.75MM
RANGER II M6, MODEL IN-888WNL
FDA 510(k)
FDA Class 2
·Physical Medicine
RF TENT
FDA 510(k)
FDA Class 2
·Radiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 18, 2013
BIZACT
FDA Adverse Event
Injury
·COVIDIEN MFG DC BOULDER·Product code GEI·August 4, 2021
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
UNK INSPIRA GEL
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·January 18, 2022
GE OEC STENOSCOPE
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 16, 2008
OPTIFLUX F250NRE DIALYZER
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·June 28, 2013
UNSPECIFIED SYSTEM
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·August 5, 2011
UNKNOWN
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HWC·April 26, 2022
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012