13 results
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22ms
·
Sources: EU EUDAMED, US FDA
SILK BLACK BRAIDED SURGICAL SUTURES, NYLON MONOFILAMENT BLUE AND BLACK SURGICAL SUTURES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600
FDA 510(k)
FDA Class 2
·Immunology
UNIPLANT DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 10, 2023
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 21, 2023
COULTER LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·March 31, 2016
PANORAMA CENTRAL STATION
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·September 16, 2014
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 6, 2011
PROXIMAL HUMERUS, RIGHT, ÿ 11X160MM
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code HSB·November 21, 2023
BLUNT TIP SCREW, ÿ 4X44MM
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code HSB·November 21, 2023
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 CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024