8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
POSTOPERATIVE UV GLASSES (PLANO/APHAKIC)
FDA 510(k)
FDA Class 1
·Ophthalmic
C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET
FDA 510(k)
FDA Class 2
·Immunology
ENDOSSEOUS DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
PESSARY FITTING SET OF 6 SIZES
FDA Adverse Event
Malfunction
·INTEGRA YORK, PA INC·Product code HHW·February 25, 2014
DIGITAL RADIOGRAPHY CXDI-70C WIRELESS
FDA Adverse Event
Malfunction
·CANON, INC.·Product code MQB·October 19, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code NBW·September 18, 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