20 results · 22ms · Sources: EU EUDAMED, US FDA

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MASS CASUALTY VENTILATOR, MODEL MCV100

FDA 510(k)
FDA Class 2 ·Anesthesiology

Pro Advantage

FDA UDI
NATIONAL DISTRIBUTION & CONTRACTING, INC.·M220P0800633·Pro Advantage HCG Urine Cassette 25/BX

NA

FDA UDI
Stryker GmbH·00886385017228·Talar Cut Guide Assembly; 2mm Paddle

Symmetry Malis®

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482139707·Titanium Malis Style Bayonet Bipolar Forceps, L...

Disposable Cuff

FDA UDI
SUNTECH MEDICAL, INC.·10840935105244·

INSPEKTOR PRO

FDA 510(k)
FDA Class 2 ·Dental

COUCH FOR TOTAL BODY RADIATION

FDA 510(k)
FDA Class 2 ·Radiology

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 5, 2024

RIATA ACTIVE FIXATION

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013

IAB: 7 FR - 30 CC

FDA Adverse Event
Malfunction ·ARROW INTL., INC.·Product code DSP·April 7, 2011

POLYFLUX LR CAPILLARY DIALYZER

FDA Adverse Event
Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·July 24, 2008

BD INTIMA-II CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·September 11, 2023

BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·August 30, 2023

RUNTHROUGH NS

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 24, 2018

BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·August 7, 2023

RUNTHROUGH NS

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 30, 2018

BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·November 22, 2023

Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

FDA Enforcement
Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

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