BEUDAMED
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    XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112564·BARRON CORNEAL PUNCH 6.0MM

    AOS CANCELLOUS SCREW 5.0mm x 70.0mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665020113·

    Persona® Trabecular Metal®

    FDA UDI
    Zimmer, Inc.·00889024470163·

    Persona® Trabecular Metal®

    FDA UDI
    Zimmer, Inc.·00889024470156·

    PERSONA™ Trabecular Metal™

    FDA UDI
    Zimmer, Inc.·00889024230255·

    PERSONA™ Trabecular Metal™

    FDA UDI
    Zimmer, Inc.·00889024230262·

    BIOLOK SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ORALLITE COMPREHENSIVE EXAM TRAY

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    NEUROFORM 3 EZ- 4.5 X 20MM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORK, LTD·Product code NJE·March 26, 2013

    MX-PRO R-3 AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·March 10, 2011

    BD PARADIGM LINK GLUCOSE MONITOR

    FDA Adverse Event
    Malfunction ·NOVA BIOMEDICAL CORP.·Product code NBW·March 28, 2008

    22G x 70mm/45 Bevel Single Shot Needle, REF 554-022-070, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code GXZ·February 1, 2010

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog Number:PB23DFCM4; 3) KIT,DIEP FLAP , Catalog Number:PB23DFCM5; 4) KIT,DIEP FLAP , Catalog Number:PB23DFCM6; 5) KIT,DIEP FLAP , Catalog Number:PB23DFCM7; 6) KIT,DIEP FLAP , Catalog Number:PB23DFCMA; 7) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ10; 8) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ11; 9) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ12; 10) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ13; 11) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ14; 12) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ15; 13) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ16; 14) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ17; 15) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ18; 16) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ19; 17) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ20; 18) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU1; 19) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU2; 20) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU3; 21) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU4; 22) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU5; 23) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU6; 24) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU7; 25) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU8; 26) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU9; 27) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUA; 28) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUB; 29) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUC; 30) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUD; 31) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUE; 32) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUF; 33) KIT, HEAD AND NECK , Catalog Number:PG40HNAJU2; 34) KIT, HEAD AND NECK , Catalog Number:PG40HNAJU3; 35) KIT, HEAD AND NECK , Catalog Number:PG40HNAJU4; 36) KIT, HEAD AND NECK , Catalog Number:PG40HNAJU5; 37) KIT, HEAD AND NECK , Catalog Number:PG40HNAJUC; 38) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ10; 39) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ11; 40) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ12; 41) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ13; 42) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ14; 43) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ15; 44) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ16; 45) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ17; 46) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ18; 47) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ19; 48) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ20; 49) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ21; 50) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ22; 51) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ23; 52) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ24; 53) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU4; 54) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU5; 55) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU6; 56) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU7; 57) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU8; 58) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU9; 59) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJUE; 60) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJUF; 61) KIT, WILLIAMS SPINE , Catalog Number:PN23WGME1; 62) KIT, WILLIAMS SPINE , Catalog Number:PN23WGME2; 63) KIT, WILLIAMS SPINE , Catalog Number:PN23WGME3; 64) KIT, WILLIAMS SPINE , Cat

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·February 19, 2025

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP1E 5) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP22 6) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP23 7) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP24 8) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP2D 9) KIT,LUMBAR LAMINECTOMY, Catalog Number:PN29LMFGA 10) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM4 11) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM5 12) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM6 13) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM7 14) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM8 15) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM9 16) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMA 17) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMB 18) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMC 19) KIT, BACK, Catalog Number:PN33BPC10 20) KIT, BACK, Catalog Number:PN33BPC11 21) KIT, BACK, Catalog Number:PN33BPCR1 22) KIT, BACK, Catalog Number:PN33BPCR2 23) KIT, BACK, Catalog Number:PN33BPCR3 24) KIT, BACK, Catalog Number:PN33BPCR4 25) KIT, BACK, Catalog Number:PN33BPCR5 26) KIT, BACK, Catalog Number:PN33BPCR6 27) KIT, BACK, Catalog Number:PN33BPCR7 28) KIT, BACK, Catalog Number:PN33BPCR8 29) KIT, BACK, Catalog Number:PN33BPCR9 30) KIT, BACK, Catalog Number:PN33BPCRA 31) KIT, BACK, Catalog Number:PN33BPCRB 32) KIT, BACK, Catalog Number:PN33BPCRC 33) KIT, MAJOR SPINE, Catalog Number:PN33MSOCG 34) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOU1 35) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOU2 36) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOUA 37) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOUB 38) KIT, JAMES SPINAL ACCESSORY, Catalog Number:PN33SAOUC 39) KIT, JAMES SPINAL ACCESSORY, Catalog Number:PN33SAOUD 40) KIT, LAMINECTOMY, Catalog Number:PN41LMMYA 41) KIT, MINOR SPINE LG MODULE, Catalog Number:PN69MSGA1 42) KIT, MINOR SPINE LG MODULE, Catalog Number:PN69MSGA2 43) KIT, MINOR SPINE LG MODULE, Catalog Number:PN69MSGA3 44) KIT, MINOR SPINE LG MODULE, Catalog Number:PN69MSGA4 45) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU2 46) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU3 47) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU4 48) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU5 49) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU6 50) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU7 51) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAUJ 52) KIT, SPINE, Catalog Number:PNCGKSPI1 53) KIT, ACDF, Catalog Number:PNMVASNL1 54) KIT, ACDF, Catalog Number:PNMVASNL2 55) KIT, ACDF, Catalog Number:PNMVASNLA 56) KIT, ACDF, Catalog Number:PNMVASNLB 57) KIT, ACDF, Catalog Number:PNMVASNLC 58) KIT, LAMINECTOMY, Catalog Number:PNMVLMNL2 59) KIT, LAMINECTOMY, Catalog Number:PNMVLMNL3 60) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLA 61) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLB 62) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLC 63) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLD 64) KIT, SPINE FUSION, Catalog Number:PNMVSF454 65) KIT, SPINE FUSION, Catalog Number:PNMVSF45A 66) KIT,CRANIOTOMY, Catalog Number:PNOCCRZA1 67) KIT,CRANIOTOMY, Catalog Number:PNOCCRZA2 68) KIT,CRANIOTOMY, Catalog Number:PNOCCRZAA 69) KIT,LAMINECTOMY, Catalog Number:PNOCLAZA1 70) KIT,LAMINECTOMY, Catalog Number:PNOCLAZAA 71) KIT, LAMINECTOMY, Catalog Number:PNOCLAZAB 72) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH11 73) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH12 74) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH13 75) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH14 76) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH15 77) SPINE, HUNTINGTON, Catalog Number:PNOCSPHTU 78) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPHTV 79) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPHTW 80) KIT, ORTHO C

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·February 19, 2025