11 results
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27ms
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Sources: EU EUDAMED, US FDA
RA 80 EIKEN KIT DETERM. OF RHEUMATIC F.
FDA 510(k)
FDA Class 2
·Immunology
ACUMED
FDA UDI
Acumed LLC·10806378097683·FFN Base Plate
KETAC-CEM IN REF. TO K802048
FDA 510(k)
FDA Class 2
·Dental
LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM).
FDA 510(k)
FDA Class 1
·General Hospital
DISPOSABLE VINYL SYNTHETIC EXAMINATION GLOVES, POWDERED
FDA 510(k)
FDA Class 1
·General Hospital
VERSYS FEMORAL HEAD
FDA Adverse Event
Malfunction
·ZIMMER·Product code JDI·February 21, 2014
XLD 110V L.A. REF
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·October 18, 2012
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·May 28, 2015
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 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