24 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOSCANNER PLUS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00887661650474·
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K01409N0·Cervical Rasp, 15 x 12, 9mm, 0 Degree, No Taper
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00887661650498·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00887661650504·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00887661650467·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033562888·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00887661650481·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00887661650511·
ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNTHES (USA) MIDFACE DISTRACTOR
FDA 510(k)
FDA Class 2
·Dental
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 27, 2012
DUAL EXTENSION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 27, 2012
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 27, 2012
SMR SHOULDER
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code HSD·May 29, 2025
SMR SHOULDER
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code HSD·May 9, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
ISOFLEX OPTIM LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011
HEARTSTREAM XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 14, 2008
The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. The Access hLH Calibrators are intended to calibrate the Access hLH assay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·December 26, 2012