20 results
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45ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SOPRO 670 ARTHROSCOPIC PUMP
FDA 510(k)
FDA Class 2
·Orthopedic
Regent
FDA UDI
SPINAL ELEMENTS·00840916114787·Regent ACP 1-Level, 22mm
Cordera Hip System Femoral Reusable Instrument Tray, insert and base
FDA UDI
Conformis, Inc.·00810933031268·Femoral Reusable Instrument Tray, insert and base
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450047477·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450179369·
Symmetry Rhoton®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482140178·Rhoton Bipolar Forceps; Bayonet; Round Handle; ...
Slimplicity Anterior Cervical Plate System
FDA UDI
PRECISION SPINE, INC.·00815362021132·1 Level 22mm Plate
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·00842331101861·Titanium Rhoton Bipolar Bayonet Forceps, round ...
COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX)
FDA 510(k)
FDA Class 2
·Orthopedic
CONTINUOUS FLOW Y-TUBING
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962108659·RHOTON BAYONET BIPOLAR FORCEPS, 9 1/2", 0.5MM T...
HOSPITAL NON-VENTED FULL FACE MASK
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code CBK·April 5, 2017
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 23, 2025
DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 17, 2008
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·April 6, 2011
AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·April 24, 2008
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 23, 2025
DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·January 9, 2013
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