12 results
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34ms
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Sources: EU EUDAMED, US FDA
DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES
FDA 510(k)
FDA Class 2
·Cardiovascular
CONVERTORS EQUIPMENT DRAPES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERESS CANNULAS WITH OUTER SHEATHS, SET
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AXXENT FLEXISHIELD MINI (K090417)
FDA Adverse Event
Injury
·XOFT, INC.·Product code IXI·January 7, 2011
PEN NDL 32G 4MM PRO 100 BOX 1200 US
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·January 6, 2025
GELPOINT SYSTEM, 100MM
FDA Adverse Event
APPLIED MEDICAL·Product code GCJ·March 26, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS INNOVATION CENTER - SILICON VALLEY·Product code GEX·March 7, 2011
ASCENSIA BREEZE2
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·April 15, 2008
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
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