BEUDAMED
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    GIRAFFE OMNIBED

    FDA 510(k)
    FDA Class 2 ·General Hospital

    4-inch ASD Excision ring blade

    FDA UDI
    EXSURCO MEDICAL, INC.·00810006780079·Amalgatome SD Surgical Skin Grafting and Debrid...

    Molar Rotation2 Appliance

    FDA UDI
    Ortho Organizers, Inc.·00190707064501·NITANIUM® MOLAR ROTATOR2 APPLIANCE (40mm)

    EVERSTICK

    FDA 510(k)
    FDA Class 2 ·Dental

    ESTATION ELECTRONIC STETHOSCOPE, MODEL DR200

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CERTAIN® GOLD-TITE® HEXED SCREW

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·April 4, 2019

    CERTAIN® GOLD-TITE® HEXED SCREW

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·April 4, 2019

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·January 15, 2026

    IMP,TSV,4.7,11.5,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·June 8, 2022

    ZERO-P CONVEX H8 PEEK

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code OVE·May 9, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 10, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS LLC (PR)·Product code NIQ·August 5, 2008

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·May 25, 2023

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·June 1, 2023

    IMP,TSV,MCOL MG,4.7MM,10M

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·September 15, 2022

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·May 9, 2023

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HET·April 5, 2023

    LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445 model: MA-03, and disposables (product#, model) [#101447, KP-05 Sulflux Plasma Separator], [#101473, HDE KP-05 Sulflux Plasma Separator], [#101785, LA-15 (AU) LDL Adsorption Column (Luer Lock Type)], [#101786, NK-M3R(UL) Tubing (Luer Lock Type)], [#101788, HDE LA-15(AU) LDL Adsorption Column (Luer Lock Type)], [#101789, HDE NK-M3R(UL) Tubing (Luer Lock Type)]. Associated labeling: 1) Instructions for Use (6): IFU LIPOSORBER LA-15 LDL Adsorption Columns FH, IFU SULFLUX KP-05 PLASMA SE-PARATOR FH, IFU TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R(UL) FH, IFU LIPOSORBER LA-15 LDL Adsorption Columns FSGS, IFU SULFLUX KP-05 PLASMA SE-PARATOR FSGS, IFU TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R(UL) FSGS, 2) Operators Manuals for the following (2): LIPOSORBER LA-15 SYSTEM OPERATOR's MANUAL FH, LIPOSORBER LA-15 SYSTEM OPERATOR's MANUAL FSGS 3) Patients Guide (1): A PATIENT GUIDE TO THE LIPOSORBER LA-15 SYSTEM FSGS

    FDA Recall
    Terminated ·Kaneka America Corp·Product code MMY·February 17, 2022

    LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445 model: MA-03, and disposables (product#, model) [#101447, KP-05 Sulflux Plasma Separator], [#101473, HDE KP-05 Sulflux Plasma Separator], [#101785, LA-15 (AU) LDL Adsorption Column (Luer Lock Type)], [#101786, NK-M3R(UL) Tubing (Luer Lock Type)], [#101788, HDE LA-15(AU) LDL Adsorption Column (Luer Lock Type)], [#101789, HDE NK-M3R(UL) Tubing (Luer Lock Type)]. Associated labeling: 1) Instructions for Use (6): IFU LIPOSORBER LA-15 LDL Adsorption Columns FH, IFU SULFLUX KP-05 PLASMA SE-PARATOR FH, IFU TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R(UL) FH, IFU LIPOSORBER LA-15 LDL Adsorption Columns FSGS, IFU SULFLUX KP-05 PLASMA SE-PARATOR FSGS, IFU TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R(UL) FSGS, 2) Operators Manuals for the following (2): LIPOSORBER LA-15 SYSTEM OPERATOR's MANUAL FH, LIPOSORBER LA-15 SYSTEM OPERATOR's MANUAL FSGS 3) Patients Guide (1): A PATIENT GUIDE TO THE LIPOSORBER LA-15 SYSTEM FSGS

    FDA Enforcement
    Class II ·Terminated·Kaneka America Corp·April 20, 2022

    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025