28 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pivot Breath Sensor
FDA 510(k)
FDA Class 2
·Anesthesiology
OptoMonitor 3
FDA UDI
Opsens Inc·07540184012060·
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112755·BARRON VACUUM PUNCH 7.5MM
16PW - Krispy Kreme FAK - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588015064·16PW - Krispy Kreme FAK - Poly White
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776165697·DEAVER RETRACTOR GRIP HANDLE
IMMULITE 2000 3GALLERGY SPECIFIC IGE
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018
TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
IMMULITE 2000 SPECIFIC ALLERGENS
FDA 510(k)
FDA Class 2
·Immunology
TGS UKA SYSTEM
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, INC·Product code HSX·March 22, 2013
IMMULITE 2000 3GALLERGY SPECIFIC IGE
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018
TGS UKA KNEE SYSTEM
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, INC.·Product code HSX·May 6, 2013
TGS UKA SYSTEM
FDA Adverse Event
Injury
·CAYENNE MEDICAL, INC·Product code HSX·February 12, 2014
TGS UKA SYSTEM
FDA Adverse Event
Injury
·CAYENNE MEDICAL, INC.·Product code HSX·September 25, 2014
TGS UKA KNEE SYSTEM
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, INC.·Product code HSX·September 10, 2013
TGS UKA KNEE SYSTEM
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, LLC·Product code HSX·August 14, 2013
COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008
CARESCAPE MONITOR B850
FDA Adverse Event
Malfunction
·GE HEALTHARE·Product code MHX·July 29, 2011
STARDRIVE SCREWDRIVER SHAFT T25/6MM HXC
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HXX·July 2, 2013
BD PHASEAL¿ L CONNECTOR C90J
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·November 4, 2022
BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene (tcdB) in human liquid or soft stool specimens fr.om patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·September 12, 2012