26 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LumiCare Caries Diagnostic Rinse
FDA 510(k)
FDA Class 2
·Dental
ReLine
FDA UDI
Nuvasive, Inc.·00195377047564·RELINE-O Trial, 5mm H Ang Left L-pop
DOYEN SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896083806·DOYEN SCISSORS STRAIGHT SERRATED BLADES POWER C...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694007214·M4 Micro Plate Organizer, Series II
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869611756·MOSS VRS distraction forceps
IRMA C02 MODEL 200101; IRMA AX 200601
FDA 510(k)
FDA Class 2
·Anesthesiology
MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL
FDA 510(k)
FDA Class 2
·Radiology
Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
FDA Enforcement
Class II
·Terminated·Bard Peripheral Vascular Inc·March 11, 2020
BD ULTRA-FINE¿ INSULIN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code FMI·April 5, 2018
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 24, 2014
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·November 4, 2015
MENTOR SMOOTH ROUND HIGH PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·February 9, 2021
PFC*SIGMA C/R NPOR FEM RT SZ 2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·January 15, 2021
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·June 12, 2020
1.5T LINX, 17 BEADS
FDA Adverse Event
Injury
·TORAX MEDICAL, INC.·Product code LEI·January 15, 2021
UNKNOWN HIP ACETABULAR CUP
FDA Adverse Event
Injury
·FINSBURY ORTHOPAEDICS LIMITED·Product code KWA·November 26, 2019
Clinical Chemistry Multiconstituent Calibrator--- List number: lE65-02
FDA Recall
Terminated
·Abbott Laboratories Diagnostic Div·Product code JIX·December 23, 2005
Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
FDA Enforcement
Class II
·Terminated·Bard Peripheral Vascular Inc·March 11, 2020