BEUDAMED
    14 results · 33ms · Sources: EU EUDAMED, US FDA

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    Design Options Spinal Tray Material Description (Material Number): SSK HACKENSACK MEDICAL CTR 20061890 (560074), SSK SUTTER COMMUNITY HOSPITAL (560214), SSK BJC HEALTH SYSTEMS (ORIGINAL CUST) (560272), SSK CA PACIFIC MED. CTR (ORIGINAL CUST) (560327), SSK TORRANCE MEMORIAL HOSPITAL (560394), SSK SURGERY ONE 20070208 (560428), SSK LUTHERN GENERAL HOSP (ORIGINAL CUST) (560462), SSK HOAG MEMORIAL HOSPITAL (560465), SSK BUPIVACAINE TRAY 2068824 (560476), SSK KAISER FOUNDATION HOSPITAL (560497), SSK THOMAS JEFFERSON UNIV HOSP (560513), SSK OVERLAKE MEDICAL CENTER (560521), SSK CUSTOM SPINAL TRAY (560523), SSK ORLANDO REGIONAL MED CENTER (560533), SSK BON SECOURS HEALTH SYS 20115122 (560538), SSK MANATEE MEMORIAL (560572), SSK MOUNT SINAI 27GA PENCAN SPINAL TRAY (560580), SSK SHANDS TEACHING HOSP. & CLINICS, INC (560584), SSK UNIVERSITY OF COLORADO (560587), SSK P25BKG (560603), SSK P24BKG (560606), SSK S25BKG (560607), SSK MAYO CLINIC - BUPIVACAINE TRAY (560609), SSK THE MEDICAL CENTER (560613), SSK PENCIL POINT SPINAL TRAY (560619), SSK EMORY ORTHO & SPINE HOSPITAL-SPINAL (560621), SSK BSW SPINAL TRAY (560628), SSK MAYO CLINIC OB DEPT - SPINAL (560645), SSK BAPTIST HOSPITAL OF MIAMI (560646), SSK MERCY GILBERT MEDICAL CENTER (560647), SSK ST.MARY'S HOSPITAL (560648), SSK HARRIS HEALTH SYSTEM (560660), OHIO STATE U MEDICAL CTR SPINAL TRAY SSK (560667), ALBANY MEDICAL CENTER, SSK (560670), STONY BROOK HOSPITAL - SPINAL TRAY SSK (560672);

    FDA Recall
    Open, Classified ·B Braun Medical Inc·Product code OFU·May 6, 2026

    R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N; (2) CBC-3D TRI PACK Hematology Control, REF 3D503, containing 4 x 2.0 mL Controls L, N, and H; (3) CBC-3D for Mythic 18 Hematology Control, REF 3D503RX, containing 2 x 2.0 mL each Controls L, N, and H; (4) CBC-3D For MINDRAY Hematology Control, REF 3D506, containing 2 x 3.0 mL each Controls L, N, and H; (5) CBC-3D For MINDRAY Hematology Control, REF 3D506US, containing 2 x 3.0 mL each Controls L, N, and H; (6) CBC-3D TRI PACK Hematology Control, REF 3D507, containing 4 x 2.0 mL each Controls L, N, and H; (7) CBC-3D TRI PACK Hematology Control, REF 3D508, containing 2 x 2.0 m each Controls L, N, and H; (8) CBC-3D For ABACUS, REF D3D02 Hematology Control, containing 2 x 3.0 mL each Controls L, N, and H; (9) CBC-3D For ABACUS Hematology Control, REF D3D04, containing 4 x 3.0 mL each Controls L, N, and H. Loose tubes labeled CBC-3D Hematology Control in 2.0mL and 3.0mL sizes. OEM/Own-label distributor labels: (1) Alere 380 Hemo Control (L-N-H), REF AL35004-KIT, containing 2 x 3.0 mL each Controls L, N, and H; Kit lot #B1122; control lot #B1122N, no UDI (2) diatron Diacon 3 Hematology Control, Normal Level, 3.0 mL tubes, lot #B1122N (3) diatron Diacon 3 Hematology Control, REF DN35002-SET, containing 6 x 3.0 mL Control N, kit lot #B1122, control lot #B1122N (4) diatron Diacon 3 Hematology Control, REF DN35004-KIT, containing 2 x 3.0 mL each Controls L, N, and H, kit lot #B1122, Normal control lot #B1122N. (5) Elite 3 HEM Control Normal, REF HEM00014, containing 6 x 3.0 mL Normal controls, kit lot #B1122, control lot #B1122N; (6) Erba H3 CON N, REF HEM00034, 3 mL vials, lot #E1122N, exp. 2023-02-10 (7) Horiba Medical Minotrol 16 Whole Blood Hematology Control, Cat. #5300000277, containing 3 x 2.5mL tubes (1 each Control 1, Control 2 (Normal), and Control 3; Cat. #5300000278, containing 6 x 2.5mL tubes (2 each Control 1, Control 2 (Normal), and Control 3; and Cat. #5300000283, containing 12 x 2.5mL tubes (4 each Control 1, Control 2 (Normal), and Control 3; kit lot #MX438, exp. 2023-01-05, Control 2 lot #MX438N. (8) 2022 3rd Test Event, CBC PLT 3 PART DIFF 2022-912-3D; and 2022 3rd Test Event, CBC PLT 3 PART DIFF 2022-914-3D. (9) mindray BC-3D, P/N 040-001423-00. (10) MINDRAY BC-3D CONTROL, REF BC3D01, containing 1 x 3.0 mL Controls L, N, and H; REF BC3D02, containing 2 x 3.0 mL Controls L, N, and H; and REF BC3D6N, containing 6 x 3.0 mL Control N; kit lot #B1122, control lot #B1122N. (11) MINDRAY BC-3D CONTROL, REF BC3D02US, containing 2 x 3.0 mL Level L, N, and H, kit lot number B1122, control lot #B1122N. (12) Nihon Kohden MEK-3D Hematology Control, REF 3DN03, containing MEK-3DN x 3 tubes; REF 3DN06, containing MEK-3DN x 6 tubes; and REF 3DN12, containing MEK-3DN x 12 tubes, kit lot #B22Y, control lot #B22YN. (13) Nihon Kohden MEK-3DN Normal Hematology Control tubes, 2.0 mL, lot #B22YN. (14) Orphee MYT-3D, REF MYT301, containing 2 x 2.5 mL Control N; REF MYT302, containing 2 x 2.5 mL each Controls L, N, and H; REF MYT304N, containing 4 x 2.5 mL Control N; REF 306N, containing 6 x 2.5 mL Control N; kit lot #B1122, control lot #B1122N; Myt-3D VET, REF MYT303-VET, containing 1 x 2.5 mL each Control L, N, and H. (15) Siemens ADVIA 360 Control, REF 11170853, containing 2 x 3.0 mL each Controls Low, Normal & High, kit lot #B0822, GTIN 00630414600833, control lot #B1122N. (16) URIT HQ-3DIFF, REF 5411000306, containing 2 x 3.0 mL each Controls L, N, and H, kit lot #B1122, control lot #B1122N; URIT HQ-3DIFF Hematology Control N tubes, 3.0 mL, lot #B1122N. (17) Woodley Haematology Control, REF WD1154, containing 6 x 2.0 mL Control N; and REF WD1154A, containing 2 x 2.0 mL each Controls L, N, and H, kit lot number B1122, control lot #B1122N;

    FDA Recall
    Open, Classified ·R & D Systems, Inc.·Product code JPK·November 7, 2022

    Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations in human serum and plasma. IFU, Part Number 750095

    FDA Recall
    Open, Classified ·R & D Systems, Inc.·Product code GGT·June 14, 2022

    SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095

    FDA Recall
    Open, Classified ·B Braun Medical Inc·Product code FJK·August 15, 2024

    STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095DA

    FDA Recall
    Open, Classified ·B Braun Medical Inc·Product code FJK·August 15, 2024

    STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096A

    FDA Recall
    Open, Classified ·B Braun Medical Inc·Product code FJK·August 15, 2024

    STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096

    FDA Recall
    Open, Classified ·B Braun Medical Inc·Product code FJK·August 15, 2024

    STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095W

    FDA Recall
    Open, Classified ·B Braun Medical Inc·Product code FJK·August 15, 2024

    STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095D

    FDA Recall
    Open, Classified ·B Braun Medical Inc·Product code FJK·August 15, 2024

    STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095L

    FDA Recall
    Open, Classified ·B Braun Medical Inc·Product code FJK·August 15, 2024

    Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A lid to a container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments. Note: The CCR basket lid is also distributed with ME764 CCR Basket - Full System

    FDA Recall
    Open, Classified ·Aesculap Implant Systems LLC·Product code FSM·February 23, 2023

    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000359 27GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000467 25GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD 8065000468 27GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A

    FDA Recall
    Open, Classified ·Alcon Research LLC·Product code NGY·August 5, 2025

    Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U

    FDA Recall
    Open, Classified ·B Braun Medical Inc·Product code FRN·August 7, 2024

    1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2000, 5" x 7", sterile; 3. Tech Medical Services, Inc. Detachable Endo Retrieval Pouch, REF TM2002, 8" x 10", sterile; 4. UNIMAX Detachable endo pocket, REF FEP936116, 3" x 6", sterile; 5. UNIMAX Detachable endo pocket, REF FEP979000, 8" x 10", sterile; 6. ConMed Corporation Detachable endo pocket, REF SB936, 3" x 6", sterile; 7. ConMed Corporation Detachable endo pocket, REF SB957, 5" x 7", sterile; 8. ConMed Corporation Detachable endo pocket, REF SB979, 7.5" x 9", sterile; 9. ConMed Corporation Detachable endo pocket, REF SB979-CA, 7.5 x 9", sterile; 10. ConMed Corporation Detachable endo pocket, REF SB936-CA, 3" x 6", sterile;

    FDA Recall
    Open, Classified ·UNIMAX MEDICAL SYSTEMS INC 8F-2, NO·Product code GCJ·June 25, 2024