25 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SHASER HRS2 HAIR REMOVAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EVO 2 ST
FDA UDI
DENTAL MANUFACTURING SPA·08056865012803·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694002691·Orbital Plate
Stryker
FDA UDI
Provision·B504OM51200800300·
RIVA Posterior Fixation System
FDA UDI
XENIX MEDICAL LLC·00840493418650·CONSTRAINED LORDOTIC ROD, 5.5mm x 80mm
RIVA Pedicle Screw System
FDA UDI
XENIX MEDICAL LLC·00840493418865·CONSTRAINED LORDOTIC ROD, 6.0mm x 80mm
OsteoMed
FDA UDI
OSTEOMED LLC·00845694063623·1.2 System Hole Orbital Plate Sterile Qty 2
NA
FDA UDI
STRYKER CORPORATION·07613154570188·1.6mm x 5.5mm Metal Cutting Heliocoidal Rasp
NA
FDA UDI
STRYKER CORPORATION·04546540078728·3.2mm x 18.3mm Metal Cutting Heliocoidal Rasp
BONART ART-E1 ELECTROSURGERY UNIT
FDA 510(k)
FDA Class 2
·Dental
REPROCESSED TROCARS, MODEL B5LT AND CB5LT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 22, 2021
SYRINGE 20ML LL S/C 48
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·May 9, 2024
BIOMET TIBIAL LOCKING BAR
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·May 20, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 25, 2014
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·June 7, 2011
SYRINGE 20ML LL S/C 48
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·May 10, 2024
EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·September 7, 2022
NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images.
FDA Enforcement
Class III
·Terminated·Nidek, Inc.·January 8, 2020
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
FDA Enforcement
Class II
·Ongoing·Auris Health, Inc·February 25, 2026