22 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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QUEST TUMOR MARKER CONTROL, MODEL 955
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496042815·ARM CARE CCL.1, SIZE M, NERO, GRADUATED COMPRES...
GOLD CORE HF PRE SOLDER
FDA 510(k)
FDA Class 2
·Dental
SAFESKIN HEALTHTOUCH POWDER-FREE EXAM GLOVE WITH VITAMIN E AND ALOE
FDA 510(k)
FDA Class 1
·General Hospital
Octane Straight
FDA UDI
Choice Spine, LP·10885862236074·
Octane Straight PC
FDA UDI
Choice Spine, LP·10885862278487·
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 21, 2025
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code NKB·April 9, 2013
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·March 30, 2011
FINELINE II EZ
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
M-LNCS Y-I
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·August 12, 2017
UNKNOWN SHOULDER LOCKING SCREW
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code PHX·August 1, 2022
UNK SHOULDER GLENOSPHERE DELTA XTEND
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code HSD·August 1, 2022
UNKNOWN SHOULDER METAGLENE
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code HSD·August 1, 2022
UNK SHOULDER HUMERAL CUP DELTA XTEND
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code HSD·August 1, 2022
UNKNOWN SHOULDER LOCKING SCREW
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code PHX·August 1, 2022
UNK SHOULDER HUMERAL STEM DELTA XTEND
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code HSD·August 1, 2022
UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code KWS·August 1, 2022
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·January 28, 2026
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·December 18, 2019