BEUDAMED
    122 results · 11ms · Sources: EU EUDAMED, US FDA

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    Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene sterilized, Non-pyrogenic, Remington Medical, Inc., Alpharetta, GA 30005.

    FDA Recall
    Terminated ·Remington Medical Inc.·Product code KNW·January 19, 2007

    Angiotech Access Needle. A) Hawkins Blunt Needle. STERILE. Product Number: 216057, 216107, 218057, 218107, 218157. 510k K881957. Qty Dist. - 3,220. B) Winged Guidewire Introducer Needle, Guidewire Introducer Needle, and "WW" Guidewire Introducer Needle. STERILE. Product Number: BGWI1802, BGWI1902, GWI1802, GWI1802WW, GWI1902. GWI1902WW. 510k K974745. Qty Dist: - 51,625. C) Introducer Sheath Needle. STERILE. Product Number: ISN1915. 510k Exempt. Qty Dist: - 1,260. D) Co-Axial Introducer Needle, and Co-Axial Needle - Biopince. STERILE. Product Number: MCXS1408SX, MCXS1409LX, MCXS1410AX, MCXS1410MX, MCXS1410TX, MCXS1412SX, MCXS1415LX, MCXS1416AX, MCXS1609LX, MCXS1610AX, MCXS1610TX, MCXS1612SX, MCXS1615LX, MCXS1616AX, MCXS1616MX, MCXS1616TX, MCXS1808SX, MXCS1809LX, MCXS1810AX, MCXS1810TX, MCXS1812SX, MCXS1815LX, MCXS1816AX, MCXS1816MX, MCXS1816SX, MCXS1816TX, MCXS1820AX, MCXS1820LX, MCXS2009LY, MCXS2010AY, MCXS2010MY, MCXS2010TY, MCXS2012SY, MCXS2015LY, MCXS2016AY, MCXS2016MY, MCXS2016SY, MCXS2016TY, MCXS1610BP, MCXS1615BP, MCXS1810BP, MCXS1815BP, MCXS1820BP. 510k K980004. Qty Dist: - 48,448. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Access Needle

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

    Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820M, 18ga (1.3mm) x 20cm (10), Remington Medical, Inc.

    FDA Recall
    Terminated ·Remington Medical Inc.·Product code KNW·February 7, 2011

    Manual Biopsy Devices containing AIM system: Chiba Needle, 8 inch/20 cm, 22 gauge, Cat. #40-103, Material #M001401031 (10 per box). Firm on label: Boston Scientific / MEDI-TECH, 480 Pleasant Street, Watertown, MA 02472.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KNW·August 9, 2004

    Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biopsy Device is used in obtaining biopsy samples from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors. For breast biopsy this product is for diagnosis onlynot therapeutic use.. These devices are sterile, single use devices.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code KNW·June 2, 2015

    Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance

    FDA Recall
    Terminated ·Devicor Medical Products Inc·Product code KNW·February 28, 2017

    Intact Disposable Wands (part of the Intact System) 777-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

    FDA Recall
    Terminated ·Medtronic Advanced Energy, LLC·Product code KNW·December 28, 2016

    Avitus Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-210 The Avitus Bone Harvester is intended to harvest cancellous bone and bone marrow

    FDA Recall
    Terminated ·Avitus Orthopaedics, Inc.·Product code KNW·February 18, 2019

    Angiotech, T-Lok Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device is intended for use during Bone Marrow Biopsy.

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code KNW·July 16, 2008

    Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

    FDA Recall
    Terminated ·Medtronic Advanced Energy, LLC·Product code KNW·December 28, 2016

    Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

    FDA Recall
    Terminated ·Medtronic Advanced Energy, LLC·Product code KNW·December 28, 2016

    EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 10G - REF ECP0110G. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code KNW·May 2, 2019

    BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code KNW·October 25, 2019

    Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G Aspiration Needle (Adjustable Length 15/16" -1-7/8") (24mm-48mm) sterile, For Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion. Original Jamshidi" Bone Marrow Biopsy/Aspiration Needle: - also referred to as Jamshidi needle Intended use for the posterior iliac crest biopsy technique

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code KNW·August 24, 2021

    Angiotech, Bone Marrow Aspiration Needle, Medical Device Technologies, Inc. Individual packaged in blister pack. Packaged 10 per box. Sterile.

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code KNW·July 16, 2008

    Temno Chiba FIne Needle Aspiration, Soft Tissue Biopsy Needle, 18 GA x 15 cm., product CHI1815, Allegiance, a Cardinal Health Company, McGaw Park, IL 60085 USA, Made in Dominican Republic

    FDA Recall
    Terminated ·Cardinal Health·Product code KNW·June 2, 2003

    ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09.

    FDA Recall
    Terminated ·Suros Surgical Systems Inc.·Product code KNW·May 25, 2006

    Suros ATEC Breast Biopsy System handpiece (9 gauge cannula 12 centimeters in length with a 20 millimeter aperture) for use with the ATEC Breast Biopsy and Excision System, disposable, sterile; Part no. 0912-20.

    FDA Recall
    Terminated ·Suros Surgical Systems Inc.·Product code KNW·December 15, 2006

    Manual Biopsy Devices containing AIM system: Co-Axial Lung Biopsy Needle, 6 inch/15 cm, 22 gauge, Cat. #40-600, Material #M001406001 (5 per box). Firm on label: Boston Scientific / MEDI-TECH, 480 Pleasant Street, Watertown, MA 02472.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KNW·August 9, 2004

    Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: 2090-0027 Needle (bullet-tip), 11 gauge x 4 inch 2090-0028 Needle (bullet-tip), 11 gauge x 6 inch 2090-0029 Needle (bullet-tip), 8 gauge x 6 inch 2090-0047 Needle (bullet-tip), 8 gauge x 8 inch 2090-0030 Needle (bullet-tip), Fenestrated, 8 gauge x 6 inch intended for use to aspirate bone marrow or autologous blood.

    FDA Recall
    Terminated ·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code KNW·December 4, 2014