20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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