BEUDAMED
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    GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    P.F.C. SIGMA

    FDA UDI
    DEPUY (IRELAND)·10603295243885·P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABIL...

    Sklar Instruments

    FDA UDI
    SKLAR CORPORATION·10649111085666·ECONO STERILE MAYO-HEGAR NH 7" STERILE CS/50

    ENDOCLAMP AORTIC CATHETER

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code DXC·June 23, 2006

    GE DATEX-OHMEDA ENGSTROM CARESTATION

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PFC SIGMA STAB+ INS 10MM SZ2

    FDA Adverse Event
    Injury ·DEPUY IRELAND - 9616671·Product code JWH·November 30, 2017

    CLYDESDALE SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH·Product code MAX·August 4, 2015

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·December 22, 2010

    12/14 ARTICUL 40MM M SPEC+5

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD - 8010379·Product code LPH·July 29, 2014

    Depuy P.F.C. E Knee System, stabilized plus tibial insert (STAB PLUS); polyethylene tibial insert, Sz 2, 10 mm; Ref 96-2710.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-2352A; 2) ECONO STERILE HALSEY NH SERR 5" STRL CS/25, Model Number 96-2353; 3) ECONO STERILE OLSEN-HEGAR NH 5.5" STRL CS/25, Model Number 96-2355A; 4) ECONO STERILE OLSEN-HEGAR NH DEL 5.5 STER 25, Model Number 96-2356A; 5) ECONO STERILE OLSEN-HEGAR NH SMO 5.5 STER 25, Model Number 96-2358A; 6) ECONO STERILE WEBSTER NH SERR JAW5.25" CS/25, Model Number 96-2417; 7) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/50, Model Number 96-2580; 8) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/25, Model Number 96-2581; 9) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/25, Model Number 96-2581A; 10) ECONO STERILE DERF NH SERR 4 3/4" STERL CS25, Model Number 96-2583; 11) ECONO STERILE DERF NH SERR 4 3/4" STERL CS25, Model Number 96-2583A; 12) ECONO STERILE HALSEY NH SMOOTH 5" STERL CS25, Model Number 96-2585; 13) ECONO STERILE HALSEY NH SMOOTH 5" STERL CS25, Model Number 96-2585A; 14) ECONO STERILE WEBSTER NH SMO 5.25" STER CS50, Model Number 96-2586; 15) ECONO STERILE WEBSTER NH SMO 5.25" STER CS25, Model Number 96-2587; 16) ECONO STERILE CRILE-WOOD NH 6" STERILE CS/50, Model Number 96-2590; 17) ECONO STERILE CRILE-WOOD NH 6" STERILE CS/25, Model Number 96-2591; 18) ECONO STERILE CRILE-WOOD NH 6" STERILE CS/25, Model Number 96-2591A; 19) ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/50, Model Number 96-2594; 20) ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/25, Model Number 96-2595; 21) ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/25, Model Number 96-2595A; 22) ECONO STERILE MAYO-HEGAR NH 5" STERILE CS/25, Model Number 96-2599; 23) ECONO STERILE WEBSTER NH SMO 5 1/4 STRL C100, Model Number 96-2659; 24) ECONO STERILE MAYO-HEGAR NH 7" STERILE CS/50, Model Number 96-2710; 25) ECONO STERILE MAYO-HEGAR NH 8" STERL CS25, Model Number 96-2711; 26) ECONO STERILE MAYO-HEGAR NH 8" STERL CS25, Model Number 96-2711A; 27) ECONO STERILE MAYO-HEGAR NH 8" STERILE CS/50, Model Number 96-2712; 28) ECONO STERILE WEBSTER NH FINE 5.25" STER 25, Model Number 96-2740A; 29) ECONO STERILE WEBSTER NH X-FIN LG 5" STER 25, Model Number 96-2741A; 30) ECONO STERILE WEBSTER NH X-FN SMO 5" STER 25, Model Number 96-2742A; 31) ECONO STERILE HALSEY NH SERR TC 5" STER CS25, Model Number 96-2745A; general orthopedic surgery

    FDA Enforcement
    Class II ·Ongoing·Sklar Instruments·January 22, 2025

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-2352A; 2) ECONO STERILE HALSEY NH SERR 5" STRL CS/25, Model Number 96-2353; 3) ECONO STERILE OLSEN-HEGAR NH 5.5" STRL CS/25, Model Number 96-2355A; 4) ECONO STERILE OLSEN-HEGAR NH DEL 5.5 STER 25, Model Number 96-2356A; 5) ECONO STERILE OLSEN-HEGAR NH SMO 5.5 STER 25, Model Number 96-2358A; 6) ECONO STERILE WEBSTER NH SERR JAW5.25" CS/25, Model Number 96-2417; 7) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/50, Model Number 96-2580; 8) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/25, Model Number 96-2581; 9) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/25, Model Number 96-2581A; 10) ECONO STERILE DERF NH SERR 4 3/4" STERL CS25, Model Number 96-2583; 11) ECONO STERILE DERF NH SERR 4 3/4" STERL CS25, Model Number 96-2583A; 12) ECONO STERILE HALSEY NH SMOOTH 5" STERL CS25, Model Number 96-2585; 13) ECONO STERILE HALSEY NH SMOOTH 5" STERL CS25, Model Number 96-2585A; 14) ECONO STERILE WEBSTER NH SMO 5.25" STER CS50, Model Number 96-2586; 15) ECONO STERILE WEBSTER NH SMO 5.25" STER CS25, Model Number 96-2587; 16) ECONO STERILE CRILE-WOOD NH 6" STERILE CS/50, Model Number 96-2590; 17) ECONO STERILE CRILE-WOOD NH 6" STERILE CS/25, Model Number 96-2591; 18) ECONO STERILE CRILE-WOOD NH 6" STERILE CS/25, Model Number 96-2591A; 19) ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/50, Model Number 96-2594; 20) ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/25, Model Number 96-2595; 21) ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/25, Model Number 96-2595A; 22) ECONO STERILE MAYO-HEGAR NH 5" STERILE CS/25, Model Number 96-2599; 23) ECONO STERILE WEBSTER NH SMO 5 1/4 STRL C100, Model Number 96-2659; 24) ECONO STERILE MAYO-HEGAR NH 7" STERILE CS/50, Model Number 96-2710; 25) ECONO STERILE MAYO-HEGAR NH 8" STERL CS25, Model Number 96-2711; 26) ECONO STERILE MAYO-HEGAR NH 8" STERL CS25, Model Number 96-2711A; 27) ECONO STERILE MAYO-HEGAR NH 8" STERILE CS/50, Model Number 96-2712; 28) ECONO STERILE WEBSTER NH FINE 5.25" STER 25, Model Number 96-2740A; 29) ECONO STERILE WEBSTER NH X-FIN LG 5" STER 25, Model Number 96-2741A; 30) ECONO STERILE WEBSTER NH X-FN SMO 5" STER 25, Model Number 96-2742A; 31) ECONO STERILE HALSEY NH SERR TC 5" STER CS25, Model Number 96-2745A; general orthopedic surgery

    FDA Recall
    Open, Classified ·Sklar Instruments·Product code HXK·December 3, 2024