18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STINGRAY LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·March 26, 2025
Stingray LP Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
STINGRAY? LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·May 29, 2026
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768451·GENUMEDI PSS GREEN I
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100356·COOK EYE SPECULUM #1 SOLID
Elevator
FDA UDI
ELLIQUENCE, LLC·00846338005443·
CMF SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036076122·
Acetal Liner Impactor 36mm
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215076191·
HEMI IMPLANT; MINI HEMI IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
GYNECARE TVT SECUR SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·June 8, 2018
TRUERESULT
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·October 3, 2014
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013
HEMOPRO2 EXTENSION CABLE
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·June 24, 2011
ProScreen 12 Panel Dip Card, Item No. PSD-12BUP
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·July 26, 2017
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024