9 results
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18ms
·
Sources: EU EUDAMED, US FDA
TRANSETTE SYSTEM/COLLECTION & TRANSP
FDA 510(k)
FDA Class 1
·Microbiology
SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT
FDA 510(k)
FDA Class 2
·Immunology
SINGLE CANNULA EXTENDED APPLICATOR
FDA 510(k)
FDA Class 1
·General Hospital
TVT DEVICE WITH PROLENE TAPE
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·May 9, 2014
PLASMABLADE TISSUE DISSECTION DEVICE
FDA Adverse Event
Malfunction
·MEDTRONIC ADVANCED ENERGY LLC·Product code GEI·October 19, 2012
LAPR-CLIP 12MM LPW
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDO·August 10, 2010
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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 GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024