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