BEUDAMED
    6,740 results · 12ms · 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 ×

    Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)

    FDA Recall
    Terminated ·GSK Consumer Healthcare·Product code N/A·April 25, 2016

    Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)

    FDA Enforcement
    Class III ·Terminated·GSK Consumer Healthcare·July 20, 2016

    BD, Francisella tularensis Antigen

    FDA Recall
    Terminated ·BD Diagnostic Systems·Product code GSK·October 20, 2004

    LPS-FLEX GSF OPT SZ C-L LPS-FLEX GSF OPT SZ C-R LPS-FLEX GSF OPT SZ D-L LPS-FLEX GSF OPT SZ D-R LPS-FLEX GSF OPT SZ E-L LPS-FLEX GSF OPT SZ E-R LPS-FLEX GSK OPT SZ F-L LPS-FLEX GSF OPT SZ F-R LPS-FLEX GSF OPT SZ G-L LPS-FLEX GSF OPT SZ G-R

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code JWH·November 29, 2017

    LPS-FLEX GSF OPT SZ C-L¿ LPS-FLEX GSF OPT SZ C-R¿ LPS-FLEX GSF OPT SZ D-L¿ LPS-FLEX GSF OPT SZ D-R¿ LPS-FLEX GSF OPT SZ E-L¿ LPS-FLEX GSF OPT SZ E-R¿ LPS-FLEX GSK OPT SZ F-L¿ LPS-FLEX GSF OPT SZ F-R¿ LPS-FLEX GSF OPT SZ G-L¿ LPS-FLEX GSF OPT SZ G-R¿

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    NexGen¿ Femoral Component (CR-FLEX GSF PRECOAT SZ C-L; CR-FLEX GSF PRECOAT SZ C-R ; CR-FLEX GSF PCT SZ C-L MINUS; CR-FLEX GSF PCT SZ C-R MINUS ;CR-FLEX GSF PRECOAT SZ D-L; CR-FLEX GSF PRECOAT SZ D-R ;CR-FLEX GSF PCT SZ D-L MINUS ; CR-FLEX GSF PCT SZ D-R MINUS ;CR-FLEX GSF PRECOAT SZ E-L CR-FLEX GSF PRECOAT SZ E-R ;CR-FLEX GSF PCT SZ E-L MINUS ;CR-FLEX GSF PCT SZ E-R MINUS ;CR-FLEX GSF PRECOAT SZ F-L ;CR-FLEX GSF PRECOAT SZ F-R ;CR-FLEX GSF PCT SZ F-L MINUS ;CR-FLEX GSF PCT SZ F-R MINUS ;CR-FLEX GSF PRECOAT SZ G-L ;CR-FLEX GSK PRECOAT SZ G-R ;CR-FLEX GSF PCT SZ G-L MINUS ;CR-FLEX GSF PCT SZ G-R MINUS ; LPS-FLEX GSF OPT SZ C-L ; LPS-FLEX GSF OPT SZ C-R ;LPS-FLEX GSF OPT SZ D-L ;LPS-FLEX GSF OPT SZ D-R ;LPS-FLEX GSF OPT SZ E-L ;LPS-FLEX GSF OPT SZ E-R ;LPS-FLEX GSK OPT SZ F-L ;LPS-FLEX GSF OPT SZ F-R ;LPS-FLEX GSF OPT SZ G-L ; LPS-FLEX GSF OPT SZ G-R ;CR-FLEX PCT FEM B-L; CR-FLEX PCT FEM B-R; CR-FLEX PCT FEM C-L; CR-FLEX PCT FEM C-R; CR-FLEX PCT FEM C-L MINUS; CR-FLEX PCT FEM C-R MINUS; CR-FLEX PCT FEM D-L; CR-FLEX PCT FEM D-R; CR-FLEX PCT FEM D-L MINUS; CR-FLEX PCT FEM D-R MINUS; CR-FLEX PCT FEM E-L; CR-FLEX PCT FEM E-R; CR-FLEX PCT FEM E-L MINUS; CR-FLEX PCT FEM E-R MINUS; CR-FLEX PCT FEM F-L; CR-FLEX PCT FEM F-R; CR-FLEX PCT FEM F-L MINUS; CR-FLEX PCT FEM F-R MINUS; CR-FLEX PCT FEM G-L; CR-FLEX PCT FEM G-R; CR-FLEX PCT FEM G-L MINUS; CR-FLEX PCT FEM G-R MINUS; CR-FLEX POR FEM B-L; CR-FLEX POR FEM B-R; CR-FLEX POR FEM C-L; CR-FLEX POR FEM C-R; CR-FLEX POR FEM C-L MINUS; CR-FLEX POR FEM C-R MINUS; CR-FLEX POR FEM D-L; CR-FLEX POR FEM D-R; CR-FLEX POR FEM D-L MINUS; CR-FLEX POR FEM D-R MINUS; CR-FLEX POR FEM E-L; CR-FLEX POR FEM E-R; CR-FLEX POR FEM E-L MINUS; CR-FLEX POR FEM E-R; MINUS; CR-FLEX POR FEM F-L; CR-FLEX POR FEM F-R ;CR-FLEX POR FEM F-L MINUS; CR-FLEX POR FEM F-R MINUS; CR-FLEX POR FEM G-L; CR-FLEX POR FEM G-R; CR-FLEX POR FEM G-L MINUS CR-FLEX POR FEM G-R MINUS; CR-FLEX OPT FEM B-L; CR-FLEX OPT FEM B-R; CR-FLEX OPT FEM C-L; CR-FLEX OPT FEM C-R; CR-FLEX OPT FEM C-L MINUS; CR-FLEX OPT FEM C-R MINUS; CR-FLEX OPT FEM D-L; CR-FLEX OPT FEM D-R; CR-FLEX OPT FEM D-L MINUS; CR-FLEX OPT FEM D-R MINUS; CR-FLEX OPT FEM E-L; CR-FLEX OPT FEM E-R; CR-FLEX OPT FEM E-L MINUS; CR-FLEX OPT FEM E-R MINUS; CR-FLEX OPT FEM F-L; CR-FLEX OPT FEM F-R; CR-FLEX OPT FEM F-L MINUS; CR-FLEX OPT FEM F-R MINUS; CR-FLEX OPT FEM G-L; CR-FLEX OPT FEM G-R; CR-FLEX OPT FEM G-L MINUS; CR-FLEX OPT FEM G-R MINUS; LPS-FLEX CO-NID FEM A-L ; LPS-FLEX CO-NID FEM A-R ; LPS-FLEX RECOAT FEMORAL A-L; LPS-FLEX PRECOAT FEMORAL A-R; LPS-FLEX CO-NID FEM B-L ; LPS-FLEX CO-NID FEM B-R ; LPS-FLEX PRECOAT FEMORAL B-L; LPS-FLEX PRECOAT FEMORL B-R; LPS-FLEX CO-NID FEM C-L ; LPS-FLEX CO-NID FEM C-R ; LPS-FLEX PRECOAT FEMORAL C-L; LPS-FLEX PRECOAT FEMORAL C-R; LPS-FLEX CO-NID FEM D-L ; LPS-FLEX CO-NID FEM D-R ; LPS-FLEX PRECOAT FEMORAL D-L; LPS-FLEX PRECOAT FEMORAL D-R; LPS-FLEX CO-NID FEM E-L ; LPS-FLEX CO-NID FEM E-R ; LPS-FLEX PRECOAT FEMORAL E-L; LPS-FLEX PRECOAT FEMORAL E-R; LPS-FLEX CO-NID FEM F-L ; LPS-FLEX CO-NID FEM F-R ; LPS-FLEX PRECOAT FEMORAL F-L; LPS-FLEX PRECOAT FEMORAL F-R; LPS-FLEX CO-NID FEM G-L ; LPS-FLEX CO-NID FEM G-R ; LPS-FLEX PRECOAT FEMORAL G-L; LPS-FLEX PRECOAT FEMORAL G-R; LPS-FLEX PRECOAT FEMORAL H-L; LPS-FLEX PRECOAT FEMORAL H-R ; LPS-FLEX POROUS FEMORAL B-L ; LPS-FLEX POROUS FEMORAL B-R ; LPS-FLEX POROUS FEMORAL C-L ; LPS-FLEX POROUS FEMORAL C-R LPS-FLEX POROUS FEMORAL D-L ; LPS-FLEX POROUS FEMORAL D-R ; LPS-FLEX POROUS FEMORAL E-L ; LPS-FLEX POROUS FEMORAL E-R ; LPS-FLEX POROUS FEMORAL F-L ; LPS-FLEX POROUS FEMORAL F-R ;LPS-FLEX POROUS FEMORAL G-L ; LPS-FLEX POROUS FEMORAL G-R ; LPS-FLEX POROUS FEMORAL H-L ; LPS-FLEX POROUS FEMORAL H-R ; LPS-FLEX OPTION FEMORAL A-L; LPS-FLEX OPTION FEMORAL A-R; LPS-FLEX OPTION FEMORAL B-L; LPS-FLEX OPTION FEMORAL B-R; LPS-FLEX OPTION FEMORAL B-L ; LPS-FLEX OPTION FEMORAL B-R ; LPS-FLEX OPTION FEMORAL C-L; LPS-FLEX OPTION FEMORAL C-R; LPS-FLEX OPTION FEMORAL C-L; LPS-FLEX OPTION FEMORAL C-R; LPS-FLEX OPTI

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·November 6, 2013

    NexGen Femoral Component (CR-FLEX GSF PRECOAT SZ C-L; CR-FLEX GSF PRECOAT SZ C-R ; CR-FLEX GSF PCT SZ C-L MINUS; CR-FLEX GSF PCT SZ C-R MINUS ;CR-FLEX GSF PRECOAT SZ D-L; CR-FLEX GSF PRECOAT SZ D-R ;CR-FLEX GSF PCT SZ D-L MINUS ; CR-FLEX GSF PCT SZ D-R MINUS ;CR-FLEX GSF PRECOAT SZ E-L CR-FLEX GSF PRECOAT SZ E-R ;CR-FLEX GSF PCT SZ E-L MINUS ;CR-FLEX GSF PCT SZ E-R MINUS ;CR-FLEX GSF PRECOAT SZ F-L ;CR-FLEX GSF PRECOAT SZ F-R ;CR-FLEX GSF PCT SZ F-L MINUS ;CR-FLEX GSF PCT SZ F-R MINUS ;CR-FLEX GSF PRECOAT SZ G-L ;CR-FLEX GSK PRECOAT SZ G-R ;CR-FLEX GSF PCT SZ G-L MINUS ;CR-FLEX GSF PCT SZ G-R MINUS ; LPS-FLEX GSF OPT SZ C-L ; LPS-FLEX GSF OPT SZ C-R ;LPS-FLEX GSF OPT SZ D-L ;LPS-FLEX GSF OPT SZ D-R ;LPS-FLEX GSF OPT SZ E-L ;LPS-FLEX GSF OPT SZ E-R ;LPS-FLEX GSK OPT SZ F-L ;LPS-FLEX GSF OPT SZ F-R ;LPS-FLEX GSF OPT SZ G-L ; LPS-FLEX GSF OPT SZ G-R ;CR-FLEX PCT FEM B-L; CR-FLEX PCT FEM B-R; CR-FLEX PCT FEM C-L; CR-FLEX PCT FEM C-R; CR-FLEX PCT FEM C-L MINUS; CR-FLEX PCT FEM C-R MINUS; CR-FLEX PCT FEM D-L; CR-FLEX PCT FEM D-R; CR-FLEX PCT FEM D-L MINUS; CR-FLEX PCT FEM D-R MINUS; CR-FLEX PCT FEM E-L; CR-FLEX PCT FEM E-R; CR-FLEX PCT FEM E-L MINUS; CR-FLEX PCT FEM E-R MINUS; CR-FLEX PCT FEM F-L; CR-FLEX PCT FEM F-R; CR-FLEX PCT FEM F-L MINUS; CR-FLEX PCT FEM F-R MINUS; CR-FLEX PCT FEM G-L; CR-FLEX PCT FEM G-R; CR-FLEX PCT FEM G-L MINUS; CR-FLEX PCT FEM G-R MINUS; CR-FLEX POR FEM B-L; CR-FLEX POR FEM B-R; CR-FLEX POR FEM C-L; CR-FLEX POR FEM C-R; CR-FLEX POR FEM C-L MINUS; CR-FLEX POR FEM C-R MINUS; CR-FLEX POR FEM D-L; CR-FLEX POR FEM D-R; CR-FLEX POR FEM D-L MINUS; CR-FLEX POR FEM D-R MINUS; CR-FLEX POR FEM E-L; CR-FLEX POR FEM E-R; CR-FLEX POR FEM E-L MINUS; CR-FLEX POR FEM E-R; MINUS; CR-FLEX POR FEM F-L; CR-FLEX POR FEM F-R ;CR-FLEX POR FEM F-L MINUS; CR-FLEX POR FEM F-R MINUS; CR-FLEX POR FEM G-L; CR-FLEX POR FEM G-R; CR-FLEX POR FEM G-L MINUS CR-FLEX POR FEM G-R MINUS; CR-FLEX OPT FEM B-L; CR-FLEX OPT FEM B-R; CR-FLEX OPT FEM C-L; CR-FLEX OPT FEM C-R; CR-FLEX OPT FEM C-L MINUS; CR-FLEX OPT FEM C-R MINUS; CR-FLEX OPT FEM D-L; CR-FLEX OPT FEM D-R; CR-FLEX OPT FEM D-L MINUS; CR-FLEX OPT FEM D-R MINUS; CR-FLEX OPT FEM E-L; CR-FLEX OPT FEM E-R; CR-FLEX OPT FEM E-L MINUS; CR-FLEX OPT FEM E-R MINUS; CR-FLEX OPT FEM F-L; CR-FLEX OPT FEM F-R; CR-FLEX OPT FEM F-L MINUS; CR-FLEX OPT FEM F-R MINUS; CR-FLEX OPT FEM G-L; CR-FLEX OPT FEM G-R; CR-FLEX OPT FEM G-L MINUS; CR-FLEX OPT FEM G-R MINUS; LPS-FLEX CO-NID FEM A-L ; LPS-FLEX CO-NID FEM A-R ; LPS-FLEX RECOAT FEMORAL A-L; LPS-FLEX PRECOAT FEMORAL A-R; LPS-FLEX CO-NID FEM B-L ; LPS-FLEX CO-NID FEM B-R ; LPS-FLEX PRECOAT FEMORAL B-L; LPS-FLEX PRECOAT FEMORL B-R; LPS-FLEX CO-NID FEM C-L ; LPS-FLEX CO-NID FEM C-R ; LPS-FLEX PRECOAT FEMORAL C-L; LPS-FLEX PRECOAT FEMORAL C-R; LPS-FLEX CO-NID FEM D-L ; LPS-FLEX CO-NID FEM D-R ; LPS-FLEX PRECOAT FEMORAL D-L; LPS-FLEX PRECOAT FEMORAL D-R; LPS-FLEX CO-NID FEM E-L ; LPS-FLEX CO-NID FEM E-R ; LPS-FLEX PRECOAT FEMORAL E-L; LPS-FLEX PRECOAT FEMORAL E-R; LPS-FLEX CO-NID FEM F-L ; LPS-FLEX CO-NID FEM F-R ; LPS-FLEX PRECOAT FEMORAL F-L; LPS-FLEX PRECOAT FEMORAL F-R; LPS-FLEX CO-NID FEM G-L ; LPS-FLEX CO-NID FEM G-R ; LPS-FLEX PRECOAT FEMORAL G-L; LPS-FLEX PRECOAT FEMORAL G-R; LPS-FLEX PRECOAT FEMORAL H-L; LPS-FLEX PRECOAT FEMORAL H-R ; LPS-FLEX POROUS FEMORAL B-L ; LPS-FLEX POROUS FEMORAL B-R ; LPS-FLEX POROUS FEMORAL C-L ; LPS-FLEX POROUS FEMORAL C-R LPS-FLEX POROUS FEMORAL D-L ; LPS-FLEX POROUS FEMORAL D-R ; LPS-FLEX POROUS FEMORAL E-L ; LPS-FLEX POROUS FEMORAL E-R ; LPS-FLEX POROUS FEMORAL F-L ; LPS-FLEX POROUS FEMORAL F-R ;LPS-FLEX POROUS FEMORAL G-L ; LPS-FLEX POROUS FEMORAL G-R ; LPS-FLEX POROUS FEMORAL H-L ; LPS-FLEX POROUS FEMORAL H-R ; LPS-FLEX OPTION FEMORAL A-L; LPS-FLEX OPTION FEMORAL A-R; LPS-FLEX OPTION FEMORAL B-L; LPS-FLEX OPTION FEMORAL B-R; LPS-FLEX OPTION FEMORAL B-L ; LPS-FLEX OPTION FEMORAL B-R ; LPS-FLEX OPTION FEMORAL C-L; LPS-FLEX OPTION FEMORAL C-R; LPS-FLEX OPTION FEMORAL C-L; LPS-FLEX OPTION FEMORAL C-R; LPS-FLEX OPTI

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JWH·August 30, 2013

    CR-FLEX GSF PRECOAT SZ C-L CR-FLEX GSF PRECOAT SZ C-R CR-FLEX GSF PRECOAT SZ D-L CR-FLEX GSF PRECOAT SZ D-R CR-FLEX GSF PRECOAT SZ E-L CR-FLEX GSF PRECOAT SZ E-R CR-FLEX GSF PRECOAT SZ F-L CR-FLEX GSF PRECOAT SZ F-R CR-FLEX GSF PRECOAT SZ G-L CR-FLEX GSK PRECOAT SZ G-R " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code JWH·November 29, 2017

    CR-FLEX GSF PRECOAT SZ C-L¿ CR-FLEX GSF PRECOAT SZ C-R¿ CR-FLEX GSF PRECOAT SZ D-L¿ CR-FLEX GSF PRECOAT SZ D-R¿ CR-FLEX GSF PRECOAT SZ E-L¿ CR-FLEX GSF PRECOAT SZ E-R¿ CR-FLEX GSF PRECOAT SZ F-L¿ CR-FLEX GSF PRECOAT SZ F-R¿ CR-FLEX GSF PRECOAT SZ G-L¿ CR-FLEX GSK PRECOAT SZ G-R¿ " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-PCAM1, g) ASK-45703-PCCH2, h) ASK-45703-PN; catheter introducer

    FDA Recall
    Terminated ·ARROW INTERNATIONAL Inc.·Product code FOZ·October 27, 2022

    PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner. This device is not intended for home use.

    FDA Recall
    Terminated ·Gsi Group Inc·Product code DSF·December 2, 2015

    ACCESS TRAY/Product SKU's (Codes) ASK-03000-CHUQ, ASK-03000-CHUQ1, ASK-04001-GFH, ASK-04001-SUH and ASK-04001-UHC. Access tray for epidural anesthesia kit

    FDA Recall
    Terminated ·Arrow International Inc·Product code CAZ·October 29, 2010

    Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Codes: ASK-42703-PAM1, ASK-42703-PSHR1, ASK-45703-PNY, ASK-45703-PWHC1

    FDA Recall
    Terminated ·Arrow International Inc·Product code FOZ·April 11, 2018

    Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQX·April 11, 2018

    Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-PCAM1, g) ASK-45703-PCCH2, h) ASK-45703-PN; catheter introducer

    FDA Enforcement
    Class I ·Terminated·ARROW INTERNATIONAL Inc.·December 21, 2022

    Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits. Product numbers: ASK-01451-BMH; ASK-05041-CHC; ASK-05041-CHC1; ASK-05041-CHM; ASK-05041-HMC; ASK-05041-QV; ASK-07041-BMH; CN-05041-LW; MSO-01451-UCL; MTO-01451-RH; PL-05041; PR-04041-HPX; PR-05041; PR-05041-HP; PR- 05041-HPX; PR-05041-LW; PR-05041-MW; PR-05041-T; PR-05042; PR-05541-HPX; PR-07041-PTSP; and RJ-01451-W.

    FDA Recall
    Terminated ·Arrow International Inc·Product code LJS·March 29, 2010

    Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·October 7, 2015

    Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·October 22, 2014

    Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kit; Product Codes: ASK-45703-PNHS; ASK-45703-PGMCL; ASK-45703-PNW; Exp. Dates Feb 2018 - Nov 2018

    FDA Recall
    Terminated ·Arrow International Inc·Product code FOZ·October 17, 2017

    Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Codes: ASK-42703-PAM1, ASK-42703-PSHR1, ASK-45703-PNY, ASK-45703-PWHC1

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 6, 2018