15 results
·
31ms
·
Sources: EU EUDAMED, US FDA
GOODKNIGHT H20, MODEL M-114600-00
FDA 510(k)
FDA Class 2
·Anesthesiology
BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
COD COMPRESSION OSTEOTOMY DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
AISYS
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·January 18, 2016
ACL TOP
FDA Adverse Event
INSTRUMENTATION LABORATORY CO.·Product code GKP·May 13, 2005
AISYS
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·January 15, 2016
ACL TOP
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code GKP·July 21, 2005
ACL ADVANCE
FDA Adverse Event
INSTRUMENTATION LABORATORY CO.·Product code JPA·April 22, 2005
ACRYSOF IQ TORIC
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·April 4, 2013
HEXHEAD SCREWDRIVER WITH UNIVERSAL JOINT
FDA Adverse Event
Malfunction
·ZIMMER INC·Product code HXX·February 15, 2011
VITALITY DS
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 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
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024