60 results
·
22ms
·
Sources: EU EUDAMED, US FDA
OPTIMESH 500E CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033953·Baltic Denture System BDLoad BDLoad ↓ Mw6 PLSEu...
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR300
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918001426·INSTANT-VIEW Multi-Drugs of Abuse Urine Test
AM...
AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM
FDA 510(k)
FDA Class 1
·General Hospital
INDIGO DIFFUSER-TIP FIBEROPTIC WITH TEMPERATURE SENSING OPTION, MODEL LF001
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 3, 2013
SD/PD LONG CURVED
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·March 23, 2011
PFC SIGMA/OV/DOME PAT 3PEG,41
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code JWH·April 24, 2008
PROGREAT
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQO·May 7, 2026
PROGREAT
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQO·May 7, 2026
PROGREAT
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQO·April 10, 2026
PROGREAT
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQO·May 7, 2026
ABRAMS MULTIDENSITY POLYURETHAN FOAM WOUND DRESSING SYSTEM
FDA Adverse Event
Other
·DR LEN'S MEDICAL PRODUCTS·Product code FRO·October 11, 2005
West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117. 510(k) No. K031953 The Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Diagnostics West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningoencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection.
FDA Enforcement
Class III
·Terminated·Focus Diagnostics Inc·November 7, 2012
PROGREAT
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQO·May 26, 2026
PROGREAT
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQO·July 28, 2025
PROGREAT
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQO·July 30, 2025
PROGREAT
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQO·August 9, 2024
PROGREAT CATHETER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQO·October 15, 2024
PROGREAT CATHETER
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DQO·December 11, 2023