15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POWER TEK II
FDA 510(k)
FDA Class 2
·Orthopedic
Safco DENTA-SAFE DENTAL DAM
FDA UDI
SAFCO DENTAL SUPPLY CO.·20810063750217·Heavy (0.23mm-0.28mm thickness) 5" x 5", green,...
SPL-50 SPIROLYSER
FDA 510(k)
FDA Class 2
·Anesthesiology
FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PACKING COIL LP
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·September 17, 2021
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·March 26, 2013
TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·March 16, 2011
9611369-2008-00149
FDA Adverse Event
Malfunction
·Product code KDI·February 20, 2008
OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY
FDA Adverse Event
Malfunction
·OGDEN MANUFACTURING PLANT·Product code KDI·July 21, 2018
Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
OPTIFLUX 180NRE DIALYZER FINISHED ASSMBLY
FDA Adverse Event
Malfunction
·OGDEN MANUFACTURING PLANT·Product code KDI·August 13, 2018
OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY
FDA Adverse Event
Malfunction
·OGDEN MANUFACTURING PLANT·Product code KDI·July 27, 2018
IMP,TSV,3.7,13,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·August 17, 2022
IMP,TSV,3.7,10,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·September 8, 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