BEUDAMED
    43 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall ×

    Custom Sterile Cardiac Cath Pack, catalog SAN25CCEAQ, Cardinal Health, McGaw Park, IL 60085 USA

    FDA Recall
    Terminated ·Cardinal Health·Product code HAP·November 15, 2003

    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 Recall
    Terminated ·Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom·Product code CIN·August 10, 2012

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

    FDA Recall
    Terminated ·Diagnostic Hybrids, Inc.·Product code CIN·July 14, 2016

    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 Recall
    Terminated ·Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom·Product code CIN·August 10, 2012

    Non-continuous ventilator accessories under the following brand names: a) REMStar Plus M US model number DS200; b) REMStar Plus M w/Humid AHP model number AHP200H; c) REMStar Plus M w/Humid US model number DS200H; d) REMStar Plus M w/Humid, w/Smartcard, AHP model number AH200HS; e) REMStar Plus M w/Smartcard, US model number DS200S; and f) REMStar Plus w/C Flex Dom model number 1009586. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code BZD·October 15, 2007

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

    FDA Recall
    Terminated ·AAP Implantate Ag Lorenzweg 5 Berlin Germany·Product code GAD·November 28, 2019

    ACCESS Ostase Part Number: 37300 Used for the quantitative measurement of bone alkaline phosphatase (BAP).

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CIN·June 22, 2011

    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 Recall
    Terminated ·Beckman Coulter Inc.·Product code JIS·October 24, 2016

    Access Ostase Calibrators, Part Number: 37305, Subsequent Product Code: JIS. 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 Recall
    Terminated ·Beckman Coulter Inc.·Product code CIN·November 10, 2011

    Access Ostase Reagent, Part Number: 37300, subsequent product code: JIS. The Access Ostase Assay is used for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Pagets disease.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CIN·November 10, 2011

    Product is packed in a pouch which is labeled as MicroChoice FOOTSWITCH Linvatec LINVATEC CORPORATION LARGO, FL 33773 USA 5020-053

    FDA Recall
    Terminated ·Linvatec Corp DBA Linvatec/Hal·Product code HWE·January 24, 2003

    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 Recall
    Terminated ·AAP Implantate Ag Lorenzweg 5 Berlin Germany·Product code KDG·January 11, 2019

    Access Immunoassay Systems Ostase Calibrators, Part Number: 37305 The Access Ostase Calibrators are used 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 Recall
    Terminated ·Beckman Coulter Inc.·Product code JIS·May 10, 2011

    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 Recall
    Open, Classified ·Product code OKV·January 7, 2026

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

    FDA Recall
    Terminated ·AAP Implantate Ag Lorenzweg 5 Berlin Germany·Product code HTW·January 25, 2019

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

    FDA Recall
    Terminated ·AAP Implantate Ag Lorenzweg 5 Berlin Germany·Product code HTW·January 25, 2019

    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 Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OKV·April 8, 2024

    MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 3) BASIC BACK CDS, REF CDS780147N; 4) INSTRUMENTED BACK CDS, REF CDS780148Q; 5) INSTRUMENTED BACK CDS, REF CDS780148R; 6) TOTAL HIP, REF CDS920027W; 7) TOTAL HIP, REF CDS920027X; 8) TOTAL HIP, REF CDS920027Y; 9) TOTAL KNEE CDS-LF, REF CDS940047AF; 10) TOTAL KNEE CDS-LF, REF CDS940047AG; 11) TOTAL HIP CDS-LF, REF CDS940048AF; 12) TOTAL HIP CDS-LF, REF CDS940048AG; 13) TOTAL HIP CDS-LF, REF CDS940048AI; 14) TOTAL KNEE, REF CDS940072W; 15) TOTAL KNEE, REF CDS940072Y; 16) TOTAL KNEE REPLACEMENT CDS, REF CDS940823AB; 17) TOTAL KNEE CDS, REF CDS940842Y; 18) TOTAL HIP CDS, REF CDS940843AA; 19) FRACTURE TABLE-LF, REF CDS940857K; 20) FRACTURE TABLE-LF, REF CDS940857L; 21) EXTREMITY-LF, REF CDS940860P; 22) EXTREMITY-LF, REF CDS940860Q; 23) KNEE/SHOULDER, REF CDS940911Q; 24) TOTAL HIP CDS, REF CDS940963Y; 25) SHOULDER CDS, REF CDS941065L; 26) TOTAL JOINT-LF, REF CDS941167M; 27) TOTAL JOINT-LF, REF CDS941167N; 28) LOWER EXTREMITY CDS-LF, REF CDS980666I; 29) LOWER EXTREMITY CDS-LF, REF CDS980666J; 30) TOTAL HIP-LF, REF CDS980788O; 31) TOTAL HIP-LF, REF CDS980788P; 32) EXTREMITY KIT, REF CDS981314R; 33) EXTREMITY KIT, REF CDS981314S; 34) ORIF HIP KIT, REF CDS981318T; 35) ORIF HIP KIT, REF CDS981318U; 36) TOTAL HIP KIT, REF CDS981320V; 37) TOTAL HIP KIT, REF CDS981320W; 38) TOTAL KNEE KIT, REF CDS981323AA; 39) TOTAL KNEE KIT, REF CDS981323Y; 40) BI LATERAL KNEE KIT, REF CDS981324T; 41) UPPER EXTREMITY CDS-LF, REF CDS981564G; 42) UPPER EXTREMITY CDS-LF, REF CDS981564I; 43) LAMI, REF CDS981886X; 44) CRANIOTOMY CDS, REF CDS981888W; 45) CRANIOTOMY CDS, REF CDS981888X; 46) TOTAL KNEE CDS, REF CDS981926D; 47) TOTAL KNEE PROCEDURE-LF, REF CDS982082F; 48) BHMC SYSTEM HIP KIT, REF CDS982396N; 49) BAPTIST NORTH TOTAL KNEE CDS, REF CDS982404M; 50) BAP NORTH SHOULDER CDS, REF CDS982406M; 51) BAP NORTH UNIV EXTREMITY CDS, REF CDS982408K; 52) TOTAL KNEE CDS, REF CDS982823Q; 53) LOWER EXTREMITY CDS-LF, REF CDS982927M; 54) LUMBAR LAMINECTOMY CDS-LF, REF CDS982928O; 55) TOTAL HIP REPLACEMENT CDS-LF, REF CDS982929K; 56) TOTAL KNEE REPLACEMENT CDS-LF, REF CDS982931L; 57) UPPER EXTREMITY-LF, REF CDS982932K; 58) LOWER EXTREMITY CDS, REF CDS982943Q; 59) LOWER EXTREMITY CDS, REF CDS982943R; 60) LOWER EXTREMITY CDS, REF CDS982943S; 61) TOTAL KNEE, REF CDS982986T; 62) SPECIALIZED HIP CDS, REF CDS983030V; 63) EXTREMITY CDS, REF CDS983031Q; 64) ZALE SPINE CDS, REF CDS983182J; 65) ZALE SPINE CDS, REF CDS983182K; 66) ZALE CRANIOTOMY CDS, REF CDS983188K; 67) DR GILL'S CDS, REF CDS983189G; 68) ZALE TOTAL KNEE CDS, REF CDS983194I; 69) ZALE TOTAL KNEE CDS, REF CDS983194J; 70) ZALE TOTAL KNEE CDS, REF CDS983194K; 71) ZALE TOTAL KNEE CDS, REF CDS983194L; 72) ZALE TOTAL HIP CDS, REF CDS983195I; 73) ZALE TOTAL HIP CDS, REF CDS983195J; 74) ZALE TOTAL HIP CDS, REF CDS983195K; 75) ZALE EXTREMITY CDS, REF CDS983199K; 76) ZALE TOTAL SHOULDER CDS, REF CDS983203J; 77) ZALE TOTAL SHOULDER CDS, REF CDS983203K; 78) ZALE TOTAL SHOULDER CDS, REF CDS983203L; 79) ORTHO EXTREMITY CDS, REF CDS983408G; 80) ORTHO-CV CDS, REF CDS983415G; 81) PODIATRY CDS, REF CDS983416D; 82) PODIATRY CDS, REF CDS983416G; 83) ORTHO EXTREMITY, REF CDS983468O; 84) LUMBAR LAMINECTOMY NEURO CDS, REF CDS983476J; 85) SITTING CERVICAL CDS, REF CDS983480G; 86) ORTHO SPINE, REF CDS983482L; 87) ARTHROSCOPY SHOULDER, REF CDS983485L; 88) EXTREMITY-LF, REF CDS983487K; 89) ACL-LF, REF CDS983490M; 90) PODIATRY CDS, REF CDS983610L; 91) TOTAL JOINT-LF, REF CDS983863F; 92) UPPER EXTREMITY CDS, REF CDS983907K; 93) UPPER EXTREMITY CDS, REF CDS983907L; 94) LOWER EXTREMITY CDS, REF CDS983909O; 95) LOWER EXTREMITY CDS, REF CDS983909P; 96) GENERAL ORTHO CDS, REF CDS983915L; 97) GENERAL ORTHO CDS, REF CDS983915M; 98) MAJOR ORTHO, REF CDS984253L; 99) LOWER EXTREMTIY, REF CDS984254K; 100) LOWER EXTREMTIY, REF CDS98425

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OJH·October 9, 2024

    FDP Plasma kit provides reagents for the detection and semi-quantitation of fibrin/fibrinogen degradation products (FDP) in plasma through the use of latex particles coated with monoclonal antibodies to FDP. The kit contains: 1 x1.3 mL vial of Reagent 1 (Latex), 1 x 20mL bottle of Reagent 2 (Buffer), 1 x 0.5mL vial of Reagent 3 (Negative Control), 1 x 0.5mL vial of Reagent 4 (Positive Control) and 10 test cards with mixing rods packaged in a predominantly white cardboard unit container. Distributed in the USA by Diagnostica Stago, Five Century Drive, Parsippany, NJ 07054.

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code DAP·December 4, 2002

    CareStream Dental Kodak 2200 Intraoral X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.

    FDA Recall
    Terminated ·Trophy Sas 4 Rue Pelloutier Croissy Beaubourg France·Product code EAP·September 18, 2012