24 results
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35ms
·
Sources: EU EUDAMED, US FDA
Dong Hai Xiang Surgical Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Packed 5D Plus Lite Scanning Unit, RMA
FDA UDI
Align Technology, Inc.·00816063021025·Wand RMAs
NA
FDA UDI
Synthes GmbH·10886982152107·5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE...
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613252254041·2.0MP LEFORT I PLATE,3MM ADVANCEMENT,R
COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST
FDA 510(k)
FDA Class 2
·Cardiovascular
CLAY-PARK LABS, INC. - LUBRICATING JELLY
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HEMOCCULT® ICT TEST DEVICE
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code KHE·June 3, 2013
6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, PUERTO RICO, B.V.·Product code MGB·October 16, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 15, 2011
OT ULTRA TEST STRIPS
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2013
METRIX AIR
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·August 7, 2019
HEMOCCULT® ICT TEST DEVICE
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code KHE·June 3, 2013
HEMOCCULT® ICT TEST DEVICE
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code KHE·June 3, 2013
HEMOCCULT® ICT TEST DEVICE
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code KHE·June 3, 2013
HEMOCCULT® ICT TEST DEVICE
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code KHE·June 3, 2013
HEMOCCULT® ICT TEST DEVICE
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code KHE·June 3, 2013
HEMOCCULT® ICT TEST DEVICE
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code KHE·June 3, 2013
HEMOCCULT® ICT TEST DEVICE
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code KHE·June 3, 2013
MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·March 22, 2025
Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·August 28, 2013