12 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ROOT CANAL POST
FDA 510(k)
FDA Class 1
·Dental
Rampart-O
FDA UDI
SPINEOLOGY INC.·M7402802515·Rampart-O
Rampart-O
FDA UDI
SPINEOLOGY INC.·M7403802515·Asm, Rampart-O
Rampart-O
FDA UDI
SPINEOLOGY INC.·M9403802515·Asm, Rampart-O
MEDLOGICS ML 4000, MODEL 4000
FDA 510(k)
FDA Class 1
·Ophthalmic
ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ASAHI REXEED-LX SERIES DIALYZER
FDA Adverse Event
Injury
·ASAHI KASEI MEDICAL CO., LTD.·Product code KDI·May 4, 2012
CONFIRM
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code MXC·May 9, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 19, 2012
S-ROM M HEAD 36MM +6
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 28, 2015
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 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