BEUDAMED
    29 results · 15ms · 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 Status: Terminated ×

    Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·August 15, 2012

    Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code NSX·June 7, 2012

    AxSYM Tricyclic Antidepressants Reagent, Distributed under the following label: AxSYM Tricyclic Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064

    FDA Recall
    Terminated ·Abbott Health Products, Inc.·Product code LDM·November 17, 2003

    10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.

    FDA Enforcement
    Class I ·Terminated·EBI Patient Care, Inc.·May 31, 2017

    Howmedica Restoration ADM Trial Cup Holder; Non Sterile; Benoist Girard, Cedex, France; Distributed by Howmedica Osteonics Corp. Mahwah, NJ. The intended use: The Restoration ADM Window Trial is locked onto the Restoration ADM Trial Cup Holder and placed into the acetabulum to evaluate the size and congruity of the preparation for visualization and assessment of fit, contact and congruency of the trial within the acetabulum.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code MEH·January 21, 2010

    10430054 Acuson with Physio Module, manufactured by Siemens Medical Solutions, Mountain View, CA.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code ITX·October 2, 2009

    Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HWA·September 30, 2013

    Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·January 1, 2014

    10041461 ACUSON S2000, manufactured by Siemens Medical Solutions, Mountain View, CA. Intended for Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/Gyn, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYO·October 2, 2009

    Abbott, ACCELERATOR Device Manager (ADM); List Number: 08H74-01; Abbott Laboratories, Abbott Park, IL

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code JQP·October 25, 2007

    10032746 Acuson Antares PE Product Version 5.0, manufactured by Siemens Medical Solutions, Mountain View, CA. Intended for Abdominal, Intraoperative, Small Parts, Transcranial, OB/Gyn, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYN·October 2, 2009

    10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.

    FDA Recall
    Terminated ·EBI Patient Care, Inc.·Product code LOE·April 20, 2017

    Acuson S2000 Ultrasound System with software and imaging. The Acuson S2000 ultrasound imaging systems are intended for these applications: fetal, abdominal, intraoperative, pediatric, small parts, transcranial, OB/GYN, cardiac, pelvic, neonatal/adult cephalic, vascular, musculoskeletal, superficial musculoskeletal, and peripheral vascular applications. Also for anatomical structures and calculation packages that provide information that provide information to the clinician...for clinical diagnosis purposes.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYN·March 1, 2010

    Stryker Restoration ADM System Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 Stryker France ZAC Satolos Green Pusignan Av de Satolas Green 69881 Mey Sieu Cedex France The Restoration ADM is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica Osteonics 22.2 mm and 28 mm diameter femoral heads.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LZO·June 3, 2011

    ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.

    FDA Enforcement
    Class II ·Terminated·LDR Spine USA, Inc.·October 12, 2016

    Stryker Restoration ADM System X3 Acetabular Insert Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; Stryker France ZAC Satolos Green Pusignan Av de Satolas Green 69881 Mey Sieu Cedex France The Restoration ADM System X# Acetabular Insert is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica Osteonics 28mm diameter femoral heads.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LZO·June 3, 2011

    ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.

    FDA Recall
    Terminated ·LDR Spine USA, Inc.·Product code LXH·August 29, 2016

    Angiotech Breast Localization Needles: A) Accura BLN and Accura II BLN with Stiffening Cannula, STERILE. Product Numbers: BLN2003, BLN2005, BLN20075, BLN2103, BLN2105, BLN21075, 266050, 266075. 510k K974741 Qty Dist. - 14,800. B) Hawkins I BLN; Hawkins II Hardware BLN, Hawkins II Flexstrand BLN. STERILE. Product Numbers: 251050, 251075, 251100, 242050, 242075, 252050, 252075. 510k K870523 Qty Dist. - 6,420. C) Hawkins III Hardwire BLN, Hawkins III Hardwire BLN with Echogenic Tip, Hawkins III Flextrand BLN. STERILE. Product Numbers: 243030, 243050, 243075, 244030, 244050, 244075, 253030, 253050, 253075. 510k 870523 Qty Dist. - 15,440. D) Homer Mammalok Gold Improved Tensile Strength. STERILE. Product Numbers: 231030G, 231050G, 231075G, 231100G, 231125G. 510k Exempt. Qty Dist. - 21,780. E) "D" Wire BLN. STERILE. Product Numbers: BLND20075. 510k K974741 Qty Dist. 230 MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Breast Localization Needle

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code GDM·September 1, 2009

    CHIBA NEEDLE MARKED, Model CNM-1806, Size: 18 GA x 15 CM, Qty: 10 each, Remington Medical, Inc., Alpharetta, GA 30005. The device is used as a General Purpose Aspiration and Injection Needle.

    FDA Recall
    Terminated ·Remington Medical Inc.·Product code GDM·April 6, 2009

    Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. The Clarity Urinalysis Reagent Strips (Urine) are for single use in professional near-patient (point-of-care) and centralized laboratory locations, and are intended for professional use only. The strips are intended for use in screening at-risk patients to assist diagnosis in the following areas: kidney function, urinary tract infections, carbohydrate metabolism (e.g. diabetes mellitus), liver function, acid-base balance and urine concentration. The results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed. The Clarity 10SG Urinalysis Reagent Strips (Urine) can be read visually , on the Clarity Urocheck 120 Urine Analyzers , and on the Clarity Urocheck 120C Urine Analyzers.

    FDA Recall
    Terminated ·Clarity Diagnostics Llc·Product code CDM·June 22, 2018