10 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BETA LACTAMASE REAGENT DISK
FDA 510(k)
FDA Class 1
·Microbiology
MARK 5 NUVO LITE OCSI AND STD
FDA 510(k)
FDA Class 2
·Anesthesiology
LUMALITE CURE LIGHT, MODEL 2100
FDA 510(k)
FDA Class 2
·Dental
LUMA ARCH
FDA Adverse Event
Injury
·LUMALITE, INC.·Product code EEG·July 6, 2004
EDM LUMBAR DRAINAGE KIT, OPEN TIP CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JXG·October 19, 2012
TENDRIL STS
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·May 9, 2014
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·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
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