30 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Molekule Air Pro RX
FDA 510(k)
FDA Class 2
·General Hospital
Waterlase Laser System Gold Handpiece
FDA UDI
Biolase, Inc.·00647529002278·A reusable contra-angled handpiece intended for...
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540256720·SCREWDRIVER
Waterlase Laser System Gold Handpiece
FDA UDI
Biolase, Inc.·00647529002483·A reusable handpiece intended for use with Wate...
STRABISMUS BABY SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896083752·STRABISMUS BABY SCISSORS STRAIGHT TUNGSTEN CARB...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694053853·M4 Autoclave Tray
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167522005000·
PTSii Personalized Tourniquet System, Twin
FDA UDI
Delfi Medical Innovations Inc·M995922005003·(Twin Channel, Single Port System) The Delfi PT...
LINER: MPACT FLAT PE HC LINER Ø36/E
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 5, 2022
SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS
FDA 510(k)
FDA Class 2
·General Hospital
DINAMAP ADVANCED NIBP MODULE
FDA 510(k)
FDA Class 2
·Cardiovascular
UNIVEC BIFURCATED SLIDING SHEATH SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
DEKA TETRA PRO COOLPEEL
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING SPA·Product code GEX·February 3, 2026
HIGH FLOW INSUFFLATION UNIT
FDA Adverse Event
Malfunction
·SHIRAKAWA OLYMPUS CO., LTD.·Product code HIF·February 10, 2025
ARCHITECT CA 19-9XR
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code NIG·November 7, 2016
PRESTIGE CERVICAL DISC SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code MJO·October 24, 2014
UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code DHA·August 11, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 1, 2013
AIM-V Medium REF AV.200/500
FDA Enforcement
Class II
·Ongoing·OXFORD IMMUNOTEC LTD·September 7, 2022
AIM-V Medium REF AV.200/500
FDA Recall
Open, Classified
·OXFORD IMMUNOTEC LTD
143 Park Road
Abingdon United Kingdom·Product code OJN·July 7, 2022