29 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Precice® Ankle Salvage System
FDA 510(k)
FDA Class 2
·Orthopedic
KeyPrint
FDA UDI
Keystone Industries·H66842004301·KeyDenture BAse Original 0.5kg
ISOLA
FDA UDI
DEPUY SPINE, LLC·10705034006635·ISOLA SPINE SYSTEM OPEN PEDICLE HOOK 4.75 x 6.5mm
LAHEY FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896060869·LAHEY FORCEPS RIGHT ANGLED LONGITUDINAL SERRATIONS
Accufit
FDA UDI
Ortho Organizers, Inc.·00190707183714·Accufit Molar Bands Lower Left First Molar 43
Triglyceride LiquiColor® (Mono)
FDA UDI
STANBIO LABORATORY, L.P.·00657498001035·For the Quantitative Enzymatic-Colorimetric Det...
AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511
FDA 510(k)
FDA Class 2
·Cardiovascular
DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NEW CORONA VIRUS NUCLEIC ACID DETECTION KIT
FDA Adverse Event
Malfunction
·PERKINELMER, INC.·Product code QJR·March 5, 2021
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·April 4, 2023
DS2ADV AUTO CPAP
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·May 27, 2024
DREAMSTATION 2 ADV AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 3, 2025
DS2ADV AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·October 8, 2024
S-ROM*SLEEVE PRX ZT HA 16D-LRG
FDA Adverse Event
Injury
·9616671 DEPUY IRELAND·Product code MEH·May 10, 2013
SROM STM ST,36+6L NK,11X16X150
FDA Adverse Event
Injury
·9616671 DEPUY IRELAND·Product code MRA·May 10, 2013
DS2ADV AUTO CPAP
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·July 30, 2024
ACCU-CHEK SPIRIT
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·May 6, 2010
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008
UNICEL® DXI 800 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·August 11, 2011
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 1, 2013