18 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM
FDA 510(k)
FDA Class 2
·Dental
COLOR SPEX
FDA UDI
FGX INTERNATIONAL INC.·00193033441893·
COLOR SPEX
FDA UDI
FGX INTERNATIONAL INC.·00193033441886·
COLOR SPEX
FDA UDI
FGX INTERNATIONAL INC.·00193033441879·
COLOR SPEX
FDA UDI
FGX INTERNATIONAL INC.·00193033441909·
ARTHREX FIBERWIRE, MODEL SPU-02NB-3800
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EZ-COMFORT TRANSPORTER 2000 SERIES
FDA 510(k)
FDA Class 1
·Physical Medicine
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 22, 2025
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·May 27, 2024
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·May 21, 2025
ASR ACETABULAR CUPS 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·March 20, 2013
UNKNOWN DEPUY 2.5 MBT TRAY
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·February 24, 2011
ASAHI MIRACLEBROS PTCA GUIDE WIRE
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES, ASAHI INTECC CO.LTD. MEDICAL DIV.·Product code DQX·March 12, 2008
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·December 21, 2016
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·November 26, 2025
Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·October 18, 2017
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - 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