19 results · 21ms · Sources: EU EUDAMED, US FDA

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PALOMAR LUX1540 HANDPIECE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

LUX 1440

FDA Adverse Event
Malfunction ·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012

KOBOT Six Stone Extractor, 6 Wires, 1.7 Fr Basket 11mm

FDA UDI
Promepla·03700512967743·

N/A

FDA UDI
BIOMET MICROFIXATION, INC·00841036027674·

MILLENNIUM

FDA UDI
Avalign Technologies, Inc.·00190776290825·Exodontia Oral Root Teaser, #36,

Adler Instrument Company

FDA UDI
Adler, Inc.·00810123205493·Exodontia Oral Root Tease

CRANIAL DRILL

FDA 510(k)
FDA Class 2 ·Neurology

PREMIER ULTRASONIC SCALER AND INSERTS

FDA 510(k)
FDA Class 2 ·Dental

TRUEBALANCE

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·April 29, 2015

TRUEBALANCE

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·August 13, 2014

TRUE BALANCE

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·February 21, 2014

TRUEBALANCE

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·September 16, 2014

TRUEBALANCE

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·October 31, 2014

TRUEBALANCE

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·October 31, 2014

TRUEBALANCE

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·January 22, 2015

EPIC II PLUS DR

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 2, 2013

EXPEDIUM 6.35 HIGHCOCR ROD W/HX450

FDA Adverse Event
Injury ·DEPUY SYNTHES SPINE·Product code NKB·September 15, 2014

ACCU-CHEK FLEXLINK PLUS

FDA Adverse Event
Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FPA·May 6, 2011

StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

FDA Enforcement
Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020