9 results · 19ms · Sources: EU EUDAMED, US FDA

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STERRAAD 100NX EXPRESS CYCLE TEST PACK

FDA 510(k)
FDA Class 2 ·General Hospital

NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE

FDA 510(k)
FDA Class 2 ·Orthopedic

AUTODIMER ASSAY MODEL # 1431

FDA 510(k)
FDA Class 2 ·Hematology

MOSAIC

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·December 11, 2025

PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

FDA Adverse Event
Malfunction ·INVACARE SUZHOU·Product code BTI·May 3, 2013

THERAKOS CELLEX SYSTEM

FDA Adverse Event
Malfunction ·THERAKOS, INC.·Product code LNR·September 10, 2014

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 5, 2011

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 REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024