BEUDAMED
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    IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP (IDS-iSYS BAP) Control Set is used for quality control of the IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

    FDA Enforcement
    Class II ·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012

    IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP Assay (IDS-iSYS BAP) is intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum or plasma on the IDS-iSYS Multi- Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of post menopausal osteoporosis and Pagets disease.

    FDA Enforcement
    Class II ·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012

    MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.

    FDA Enforcement
    Class II ·Terminated·Diagnostic Hybrids, Inc.·May 16, 2018

    aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00

    FDA Enforcement
    Class II ·Terminated·AAP Implantate Ag·April 15, 2020

    Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·November 23, 2016

    aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support during orthopedic surgeries. If not otherwise specified, instruments are intended for multiple use.

    FDA Enforcement
    Class II ·Terminated·AAP Implantate Ag·March 27, 2019

    ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869050775 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·August 28, 2019

    ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869030005 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·August 28, 2019

    ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004303 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·August 28, 2019

    ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004297 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·August 28, 2019

    INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425

    FDA Enforcement
    Class III ·Terminated·AAP Implantate Ag·January 1, 2020

    INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453

    FDA Enforcement
    Class III ·Terminated·AAP Implantate Ag·January 1, 2020

    Artix MT Thrombectomy Device, REF: 32-102

    FDA Enforcement
    Class II ·Ongoing·Inari Medical - Oak Canyon·May 14, 2025

    ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011

    FDA Enforcement
    Class I ·Ongoing·Inari Medical - Oak Canyon·August 28, 2024

    CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.

    FDA Enforcement
    Class II ·Terminated·LAP of America Laser Applications, LLC·June 11, 2014

    LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi projection format that defines isocenters, field and MLC contours along with a 3D patient view.

    FDA Enforcement
    Class II ·Terminated·LAP of America Laser Applications, LLC·July 2, 2014

    Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number DYNJ0589795V; 2) CATARACT CM-LF, Pack Number DYNJ39921B; 3) CATARACT EYE, Pack Number DYNJ45662C; 4) CATARACT PACK, Pack Number DYNJ56056B; 5) CATARACT PACK, Pack Number DYNJ56553B; 6) CATARACT PACK, Pack Number DYNJ0417156G; 7) CATARACT PACK, Pack Number DYNJ60411A; 8) CATARACT PACK, Pack Number DYNJ52649F; 9) CATARACT PACK - 30843, Pack Number DYNJVB1076B; 10) CATARACT PACK-LF, Pack Number DYNJ0317858M; 11) CATARACT-LF, Pack Number DYNJ40081F; 12) ENT PACK, Pack Number DYNJ38916B; 13) EYE CATARACT PK, Pack Number DYNJ46557K; 14) EYE CATARACT PK, Pack Number DYNJ46557L; 15) EYE PACK, Pack Number DYNJ48800C; 16) EYE PACK, Pack Number DYNJ38494G; 17) EYE PACK, Pack Number DYNJ21134A; 18) EYE PACK 1, Pack Number DYNJHTEY01; 19) EYE PACK II-LF, Pack Number DYNJ50237A; 20) EYE PBM-LF, Pack Number DYNJ0190619G; 21) MZ GENERAL EYE PACK, Pack Number DYNJ66623A; 22) OCULAR PLASTICS, Pack Number DYNJ82032; 23) OPHTHALMOLOGY PACK, Pack Number DYNJ52885D; 24) OPHTHALMOLOGY PACK, Pack Number DYNJ52885F; 25) PK, OPHTH-RETINA, Pack Number DYNJ45046A; 26) PLASTIC PACK, Pack Number DYNJ82060A; 27) RETINAL DSC, Pack Number DYNJ68940A; 28) SMSC- EYE PACK HOSP&CLINIC-LF, Pack Number DYNJ0780084F; 29) STRABISMUS PACK-LF, Pack Number DYNJ0789014K; 30) RETINAL PACK, Pack Number LYN030REFCA; 31) EYE PACK WHITEWATER SC, Pack Number VAL038EPWSB

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 2, 2025

    Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431J; 4) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 5) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431L; 6) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431N; 7) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O; 8) KIT ROBOTICS GYN, Model Number: DYKMBNDL109A; 9) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116A; 10) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116G; 11) ROBOTIC PACK, Model Number: DYNJ04135B; 12) MINOR LITHOTOMY PACK, Model Number: DYNJ04382J; 13) NBMC D & C PACK-LF, Model Number: DYNJ0665843C; 14) D&C PACK-LF, Model Number: DYNJ22567G; 15) D&C PACK-LF, Model Number: DYNJ22567I; 16) D&C PACK-LF, Model Number: DYNJ22567J; 17) D&C PACK-LF, Model Number: DYNJ22567K; 18) D&C HYSTEROSCOPY PACK, Model Number: DYNJ38805B; 19) D AND C, Model Number: DYNJ41272B; 20) D AND C, Model Number: DYNJ41272C; 21) OB PACK, Model Number: DYNJ42884; 22) D&C/GYN PACK, Model Number: DYNJ47713A; 23) PERI GYN PACK, Model Number: DYNJ55377D; 24) ANTERIOR CERVICAL-LF, Model Number: DYNJ58344; 25) D&C PACK, Model Number: DYNJ67214D; 26) D&C PACK, Model Number: DYNJ67214F; 27) D&C PACK, Model Number: DYNJ67214G; 28) D&C PACK, Model Number: DYNJ67214I; 29) LITHOTOMY PACK, Model Number: DYNJ80765C; 30) GYN PACK, Model Number: DYNJ83475; 31) D AND C PACK, Model Number: DYNJ87468; 32) D&C-ASC, Model Number: DYNJ900465C; 33) D&C-ASC, Model Number: DYNJ900465D; 34) D&C-ASC, Model Number: DYNJ900465F; 35) GYN LITHOTOMY-LF, Model Number: DYNJ902711L; 36) GYN LITHOTOMY-LF, Model Number: DYNJ902711N; 37) D&C, Model Number: DYNJ906947C; 38) PACK PERI GYN DSMC, Model Number: DYNJT6424

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 13, 2026

    Medline Convenience kits labeled as: 1) LABOR & DELIVERY CDS, Pack Number CDS830039AD; 2) FETAL SURGERY CDS-LF, Pack Number CDS840214P ; 3) OB PROCEDURE-LF , Pack Number CDS981335C ; 4) ROBOTIC PACK-LF , Pack Number CDS981757P ; 5) GYN ROBOTIC , Pack Number CDS981826J ; 6) ROBOTIC CDS , Pack Number CDS981882Q ; 7) ROBOTIC CDS , Pack Number CDS981882R ; 8) ROBOTIC UROLOGY CDS , Pack Number CDS981984I ; 9) D&C CDS-WRMC, Pack Number CDS982331N ; 10) LITHOTOMY CDS-WRMC, Pack Number CDS982333O ; 11) LITHOTOMY CDS-WRMC, Pack Number CDS982333P ; 12) DEPAUL DAVINCI CDS, Pack Number CDS982377G ; 13) BAP NORTH BASIC MINOR GYN CDS , Pack Number CDS982397B ; 14) BAP NORTH ROBOTIC SURGERY CDS , Pack Number CDS982407N ; 15) GYN/ABDOMINAL , Pack Number CDS982725M ; 16) ROBOTIC CDS , Pack Number CDS982888D ; 17) ROBOTIC CDS , Pack Number CDS982888F ; 18) ROBOTIC CDS , Pack Number CDS982888G ; 19) ROBOTIC CDS , Pack Number CDS983028D ; 20) ZALE PUMP CDS , Pack Number CDS983187F ; 21) CUH UROLOGY ROBOTIC CDS , Pack Number CDS983190L ; 22) ROBOTIC PROSTATECTOMY CDS , Pack Number CDS983216I ; 23) ROBOTIC CDS-LF, Pack Number CDS983258O ; 24) ROBOTIC CDS-LF, Pack Number CDS983258Q ; 25) VAGINAL MINOR , Pack Number CDS983268K ; 26) CUH GEN/GYN ROBOTIC CDS , Pack Number CDS983375K ; 27) ROBOTIC CDS , Pack Number CDS983399D ; 28) GYN VAGINAL CDS , Pack Number CDS983528L ; 29) GYN VAGINAL CDS , Pack Number CDS983528M ; 30) CELEBRATION ROBOTIC CDS , Pack Number CDS983612C ; 31) DAVINCI PROSTATECTOMY CDS , Pack Number CDS983667F ; 32) ROBOTIC LAP NISSEN CDS, Pack Number CDS983687F ; 33) OB CDS, Pack Number CDS983854B ; 34) OB/GYN CDS, Pack Number CDS984173F ; 35) GROTH VAGINAL , Pack Number CDS984201V ; 36) ROBOTIC LITHOTOMY , Pack Number CDS984454N ; 37) DAVINCI ROBOTIC CDS , Pack Number CDS984463C ; 38) DAVINCI CDS UCC-LF, Pack Number CDS984663G ; 39) GYN CDS , Pack Number CDS984860G ; 40) OB DELIVERY CDS , Pack Number CDS985027I ; 41) OB/GYN CDS RICE , Pack Number CDS985256C ; 42) OB/GYN CDS RICE , Pack Number CDS985256D ; 43) OB/GYN CDS RICE , Pack Number CDS985256F ; 44) OB CDS-LF , Pack Number CDS985320C ; 45) OB, Pack Number CDS985506D ; 46) OB, Pack Number CDS985506F ; 47) OB, Pack Number CDS985506G ; 48) OB, Pack Number CDS985506I ; 49) GYN LAPAROSCOPY , Pack Number CDS985519L ; 50) KIT ROBOTICS GYN, Pack Number DYKMBNDL109A ; 51) TRAY HYSTEROSALPINGOGRAM, Pack Number DYNDE1010A ; 52) PERI-GYN PACK-LF, Pack Number DYNJ0038057; 53) ROBOTICS PACK-LF, Pack Number DYNJ0038258B ; 54) DAVINCI PACK-LF , Pack Number DYNJ0042750; 55) ROBOTICS PACK-LF, Pack Number DYNJ0046667A ; 56) ROBOTIC PACK-LF , Pack Number DYNJ0048814I ; 57) NILES LAP PELVIC PACK-LF, Pack Number DYNJ0101440F ; 58) OB DELIVERY PACK-LF , Pack Number DYNJ0103039B ; 59) D AND C PACK-LF , Pack Number DYNJ0161028C ; 60) D AND C PACK-LF , Pack Number DYNJ0161028F ; 61) D AND C PACK-LF , Pack Number DYNJ0161028G ; 62) PELVISCOPY (SMSC) PACK-LF , Pack Number DYNJ0161619D ; 63) LAP SUPRA CERVICAL PACK-LF, Pack Number DYNJ0161811C ; 64) ROBOT PACK, Pack Number DYNJ01823F ; 65) ROBOTICS PACK-LF, Pack Number DYNJ0193529A ; 66) DELIVERY ROOM PACK-LF , Pack Number DYNJ0287784R ; 67) OB PACK , Pack Number DYNJ03387A ; 68) PERI GYN PACK-LF, Pack Number DYNJ0362432L ; 69) PERI GYN PACK-LF, Pack Number DYNJ0362432M ; 70) OB PACK-LF, Pack Number DYNJ0367126L ; 71) OB PACK-LF, Pack Number DYNJ0367126M ; 72) OB PACK-LF, Pack Number DYNJ0367126N ; 73) BIRTHING PACK-LF, Pack Number DYNJ0367360K ; 74) BIRTHING PACK-LF, Pack Number DYNJ0367360L ; 75) OB DELIVERY PACK-LF , Pack Number DYNJ0374609J ; 76) ANTERIOR CERVICAL PACK-LF , Pack Number DYNJ0378293K ; 77) ANTERIOR CERVICAL PACK-LF , Pack Number DYNJ0378634F ; 78) GENERAL MATERNITY PACK-LF , Pack Number DYNJ0382586I ; 79) ANT CERVICAL DISKECT PACK-LF, Pack Number DYNJ0399835M ; 80) BIRTHING PACK-LF, Pack Number DYNJ0409968D ; 81) AOP/VAGINAL MAJOR PACK-LF , Pack Number DYNJ

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number: CDS981504G; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407P; 3) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 4) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 5) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G; 6) ROBOTIC-LF, Model Number: CDS984543D; 7) ROBOTIC-LF, Model Number: CDS984543F; 8) ROBOTIC-LF, Model Number: CDS984543G; 9) ROBOTIC-LF, Model Number: CDS984543I; 10) GYN CDS, Model Number: CDS984860F; 11) GYN LAP PELVI, Model Number: CDS985423G; 12) GYN KIT, Model Number: DYKM1657A; 13) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL100; 14) KIT ROBOTICS GYN, Model Number: DYKMBNDL109; 15) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116D; 16) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116F; 17) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119; 18) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119A; 19) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168; 20) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168A; 21) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184D; 22) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91;

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 13, 2026