24 results · 21ms · Sources: EU EUDAMED, 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