11 results · 26ms · Sources: EU EUDAMED, US FDA

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SALEM/RESCE INTUBATION GUIDE

FDA 510(k)
FDA Class 1 ·Anesthesiology

Bardia® Urethral Catheter

FDA UDI
C. R. Bard, Inc.·00801741018367·Bardia® Urethral Catheter - Red Rubber

GOLDEN-RULE SCALING CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

IBA PROTON THERAPY SYSTEM- PROTEUS 235

FDA 510(k)
FDA Class 2 ·Radiology

RESOLUTE INTEGRITY RX

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code NIQ·October 24, 2012

HEARTSTART ONSITE

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 21, 2014

LUMINOS AGILE

FDA Adverse Event
Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code JAA·May 26, 2015

IVAC

FDA Adverse Event
Malfunction ·ALARIS MEDICAL SYSTEMS, INC.·Product code FPA·October 30, 1998

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