22 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040018989·Zirlux ST1 98.5X30mm
TEWA
FDA UDI
asia-med GmbH·04251282514327·TeWa CB-Type 1413: coated acupuncture needles ...
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033364253·
GLOBAL BY <GENX> BLASTOCYST MEDIA
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OMNIPORT HAND AND INSTRUMENT ACCESS DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TEMPUS PRO
FDA Adverse Event
Malfunction
·REMOTE DIAGNOSTIC TECHNOLOGIES LTD.·Product code MHX·August 14, 2024
ENDOPATH ETS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·November 7, 1997
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 16, 2007
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 12, 2013
ELECTRIC DERMATOME HANDPIECE
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code GFD·January 31, 2011
CEMENT, BONE, VERTEBROPLASTY
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code NDN·October 9, 2014
CEMENT, BONE, VERTEBROPLASTY
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code NDN·October 9, 2014
CEMENT, BONE, VERTEBROPLASTY
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NDN·October 9, 2014
CEMENT, BONE, VERTEBROPLASTY
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code NDN·October 9, 2014
CEMENT, BONE, VERTEBROPLASTY
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code NDN·October 9, 2014
ZENITH ®TX2® LOW PROFILE TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code MIH·March 10, 2017
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024