13 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Allergen-Specific IgE Assay 12 Allergen Bundle
FDA 510(k)
FDA Class 2
·Immunology
VERTE-STACK® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074520858·SPACER 9193613 CRESCENT PEEK 36X13
Edge™ Diamond TS016-10M Tapered Shoulder
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172003612·Diamond dental bur, reusable
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198390·AK3 PS Insert Trial Size 6, 13mm
VASCUVIEW TAP ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
INPECTRA STO2 SPOT CHECK
FDA 510(k)
FDA Class 2
·Cardiovascular
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 22, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 25, 2013
MERIT CUSTOM KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·July 14, 2011
STYLE 68 SALINE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·July 26, 2017
BD MAX¿ CPO
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·May 13, 2025
BD MAX¿ CPO
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·January 21, 2025
Quanta System Sterile Optical Laser Fiber, single use
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·June 16, 2021