13 results · 21ms · Sources: EU EUDAMED, 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