9 results
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29ms
·
Sources: EU EUDAMED, US FDA
TSH RADIOIMMUNOASSAY KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113509·MINIATURE BLADE #67 (BX/5)
COALIZA PROTEIN S-FREE
FDA 510(k)
FDA Class 2
·Hematology
ENSITE FUSION DYNAMIC REGISTRATION TOOL
FDA 510(k)
FDA Class 2
·Cardiovascular
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 21, 2014
AMBIENT SUPER TURBOVAC 90 WITH IFS
FDA Adverse Event
Malfunction
·ARTHROCARE CORPORATION·Product code GEI·October 18, 2012
RESOLUTION HEMOSTASIS CLIPPING DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·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