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

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RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP

FDA 510(k)
FDA Class 2 ·Ophthalmic

ENCORE POWDER-FREE LATEX SURGICAL GLOVES, ORTHOPAEDIC WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE

FDA 510(k)
FDA Class 2 ·Physical Medicine

WAVEWRITER ALPHA?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·July 28, 2025

RICH-MAR WINNER CM2

FDA Adverse Event
Injury ·RICH-MAR·Product code IPF·March 1, 2012

AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code FNL·April 29, 2013

ISOFLEX OPTIM LEAD

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 10, 2011

ACCU-CHEK COMPACT TEST DRUM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 24, 2008

BD PLATE CAMPYLOBACTER SB 100MM

FDA Adverse Event
Malfunction ·BECTON DICKINSON DE MEXICO·Product code JSJ·June 2, 2022

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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