9 results
·
22ms
·
Sources: EU EUDAMED, US FDA
ESTRIOL-SQUIBB RIA KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems
FDA 510(k)
FDA Class 2
·Radiology
RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER
FDA 510(k)
FDA Class 2
·Anesthesiology
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·February 21, 2014
NAVIGATOR 12MM X 26MM X 4DEG
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MAX·October 18, 2012
LIFESTYLES X2
FDA Adverse Event
Other
·SURETEX LTD.·Product code HIS·August 9, 2010
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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