10 results · 28ms · Sources: EU EUDAMED, 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