9 results
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18ms
·
Sources: EU EUDAMED, US FDA
COBAS REAGENT FOR CHOLESTEROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Precept
FDA UDI
Nuvasive, Inc.·00887517352194·PRECEPT Dilator, Reduction Screw
PREFERENCE PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SPINAL CORD AND IMMOBILIZATION TRACTION SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
UNIFY CRT-D, DF4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·May 8, 2014
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·October 23, 2012
FREESTYLE FREEDOM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 21, 2007
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