15 results · 31ms · Sources: EU EUDAMED, US FDA

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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