11 results · 23ms · Sources: EU EUDAMED, US FDA

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ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS

FDA 510(k)
FDA Class 2 ·Immunology

INFINION CX

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 20, 2023

MMO-202N THREE-AXIS JOYSTICK OIL HYDRAULIC MICROMANIPULATOR

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

REPROCESSED COMPRESSION LIMB SLEEVES

FDA 510(k)
FDA Class 2 ·Cardiovascular

SIMULUS SEMI-RIGID ANNULOPASTY RING

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 10, 2020

VITEK 2 AST-P606 ANTIMICBROBIAL SUSCEPTIBILITY TEST KIT

FDA Adverse Event
Malfunction ·BIOMÉRIEUX, INC.·Product code LON·February 23, 2015

KMEDIC WILDE IVD RONG. 5" STR. 6X11MM

FDA Adverse Event
Malfunction ·KMEDIC GMBH, PILLING WECK, TELEFLEX MEDICAL·Product code HAE·April 19, 2013

RHEO KNEE

FDA Adverse Event
Injury ·OSSUR·Product code IQI·April 21, 2011

ENTRUST VR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code LWS·July 10, 2008

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

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52, REF 106-22-52; g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54, REF 106-22-54; h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48, REF 106-28-48; i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50, REF 106-28-50; j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52, REF 106-28-52; k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54, REF 106-28-54; l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56, REF 106-28-56; m. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58, REF 106-28-58; n. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60, REF 106-28-60; o. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52, REF 106-32-52; p. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54, REF 106-32-54; q. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56, REF 106-32-56; r. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58, REF 106-32-58; s. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60, REF 106-32-60

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022