9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
TEST KIT FOR DETECTION OF HERPES SIMPLEX
FDA 510(k)
FDA Class 2
·Microbiology
Bardia® Coude Olive Tip Urethral Foley Catheter
FDA UDI
C. R. Bard, Inc.·00801741039102·Bardia® Coude Olive Tip Urethral Catheter
CARDIO VUE QUANTITATIVE ANALYSIS (CVQ)
FDA 510(k)
FDA Class 2
·Radiology
BLO2X OXYGEN BLOCKER
FDA 510(k)
FDA Class 2
·Dental
REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET
FDA Adverse Event
Malfunction
·SYNTHES SALZBURG·Product code HTD·May 9, 2014
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 19, 2012
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·August 17, 2010
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