23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CS 2200
FDA UDI
CARESTREAM HEALTH, INC.·60889975153605·CS 2200 110V/188CM STD WALL MTD
CS 2200
FDA UDI
CARESTREAM DENTAL LLC·60192155153600·CS 2200 110V/188CM STD WALL MTD
SPHERICAL AMALGAM
FDA UDI
BENCO DENTAL SUPPLY CO.·D744315360607·EON ORIG SPHERICAL #3 FAST 500
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180526385·Flat ALIF Ring Curette 6mm
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383507783·Gutta Percha Points is used to root canal filin...
BE PLUS / AURA-LTM64 AMPLIFIER
FDA 510(k)
FDA Class 2
·Neurology
ARTISTE SOLUTION WITH SYS_VB50 UPDATE
FDA 510(k)
FDA Class 2
·Radiology
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 6, 2019
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·February 12, 2018
CART 9734056 S7 STAFF SHRT 100-120V INTL
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019
STEALTHSTATION® S7
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·March 18, 2019
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·October 8, 2014
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code NIK·June 8, 2013
ENDOTAK PLUS
FDA Adverse Event
Injury
·HISTORICAL PUERTO RICO·Product code NVY·July 7, 2011
CUP: VERSAFITCUP ACETABULAR SHELL 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·March 2, 2021
SYNGO SUITE FOR ONCOLOGY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code MUJ·November 9, 2012
9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·November 4, 2020
9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·November 4, 2020