13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NACERA Z AND NACERA Z MEDIUM
FDA 510(k)
FDA Class 2
·Dental
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014604992·BERCHTOLD OPERON D850, D750 2" DELUXE
LEONE SPA
FDA UDI
LEONE SPA·08033707000976·MICRO SECT SCREWS S/STEEL 10mm
CRANIAL DRILL
FDA 510(k)
FDA Class 2
·Neurology
PREMIER ULTRASONIC SCALER AND INSERTS
FDA 510(k)
FDA Class 2
·Dental
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 14, 2024
RIATA ST OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013
HS III PROXIMAL SEAL SYSTEM 4.3MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC.·Product code DXC·April 7, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·July 22, 2008
UNKNOWN AGC KNEE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 23, 2014
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