BEUDAMED
    68 results · 17ms · Sources: EU EUDAMED, US FDA

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    LATITUDE Paceart Integration Software, version 1.00 Model 6472. LATITUDE Paceart Integration is software and therefore does not have any serial numbers. However, the software version affected is version 1.00 and is distributed on USB pen drives. These pen drives are lot number controlled and denoted as Model 6493. When used in conjunction with the LATITUDE EMR Integration software transfers data files from the Boston Scientific LATITUDE Patient Management system to a clinic's Paceart system.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code LWS·August 12, 2011

    Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002

    FDA Recall
    Terminated ·Product code OLO·September 22, 2019

    CVC BUNDLE, 20CM, 3L, PI ECVC5120

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code OES·April 24, 2019

    CVC BUNDLE, 20CM, 4L, PI ECVC5095

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code OES·April 24, 2019

    CVC BUNDLE, 20CM, 3L, PI ECVC5120A

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code OES·April 24, 2019

    Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI OPI (300) Uncut Sheet-Card /187876, 100195/ EDI PPX Uncut Sheet-Card/ 187877, 160130/ EDI COC Uncut Sheet-Cup/ 188168, 160180/ EDI PCP Uncut Sheet-Cup/ 189027, 160140/ EDI THC Uncut Sheet Cup /189028, 160170/ EDI BZO Uncut Sheet-Cup/ 189081, 160120/ EDI MET1000 Uncut Sheet-Cup/ 189082, 160160/ EDI OPI2000 Uncut Sheet-Cup / 189123, 160130/ EDI COC Uncut Sheet-Cup/ 189124, 160160/ EDI OPI2000 Uncut Sheet-Cup/ 189166, 160163/ EDI OPI (300) Uncut Sheet-Cup/ 189191, 160110/ EDI AMP Uncut Sheet-Cup/ 189371, 160140/ EDI THC Uncut Sheet Cup/ 189372, 160123/ EDI MET(300) Uncut Sheet-Cup/ 189425, 160170/ EDI BZO Uncut Sheet-Cup/ 189426, 100163/ EDI OPI (300) Uncut Sheet-Card/ 189456, 160170/ EDI BZO Uncut Sheet-Cup/ 189565, 160180/ EDI PCP Uncut Sheet-Cup/ 189601, 160125/ EDI MET(500) Uncut Sheet-Cup/ 189748, 160130/ EDI COC Uncut Sheet-Cup/ 189786, 160160/ EDI OPI2000 Uncut Sheet-Cup / 189844, 160180/ EDI PCP Uncut Sheet-Cup/ 189937, 160172/ EDI BZO(200) Uncut Sheet-CUP/189956 Updated 09/03/2020: EDI Affected products -Catalog Numbers/ Lot Numbers 31105-3/ PI-01081 60503s-3ZC/ PH-10132 60600/ PH-11005

    FDA Recall
    Terminated ·Ameditech Inc·Product code DIO·August 18, 2020

    Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code EPY·February 23, 2024

    Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black

    FDA Recall
    Terminated ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code IPY·February 24, 2016

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2237M; 3) ECONO STERILE VIENNA NSL SPEC LG STRL CS/25, Model Number 96-2238; for nasal procedures

    FDA Recall
    Open, Classified ·Sklar Instruments·Product code EPY·December 3, 2024

    BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier environment to protect patient from infection.

    FDA Recall
    Terminated ·Dukal Corp.·Product code FPY·June 1, 2017

    Insignia Plus Multiprogrammable Pacemaker, DDDR Model 1295

    FDA Recall
    Terminated ·Guidant Corp-Cpi Division·Product code DXY·May 6, 2003

    Meridian Multiprogrammable Pacemaker, DDDR Model 1276

    FDA Recall
    Terminated ·Guidant Corp-Cpi Division·Product code DXY·May 6, 2003

    Insignia Entra Multiprogrammable Pacemaker, DDDR Model 1297

    FDA Recall
    Terminated ·Guidant Corp-Cpi Division·Product code DXY·May 6, 2003

    Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary Sinus - Extended Hook Tip Shape, CS-Extended H, REF 6778

    FDA Recall
    Terminated ·Guidant Corp-Cpi Division·Product code DQR·March 11, 2004

    Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, CS Wide Tip Shape, CS-W, REF 6705

    FDA Recall
    Terminated ·Guidant Corp-Cpi Division·Product code DQR·March 11, 2004

    Discovery II Multiprogrammable Pacemaker, Model 1284

    FDA Recall
    Terminated ·Guidant Corp-Cpi Division·Product code DXY·June 23, 2003

    Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary Sinus - Extended Hook Right Tip Shape, CS-EH R, REF 7592

    FDA Recall
    Terminated ·Guidant Corp-Cpi Division·Product code DQR·March 11, 2004

    Discovery Multiprogrammable Pacemaker, DDDR Model 1273

    FDA Recall
    Terminated ·Guidant Corp-Cpi Division·Product code DXY·May 6, 2003

    Pulsar Multiprogrammable Pacemaker, DDDR Model 1272

    FDA Recall
    Terminated ·Guidant Corp-Cpi Division·Product code DXY·May 6, 2003

    Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Lenght 54 cm, Coronary Sinus - Extended Hook Right Tip Shape, CS-EH R, REF 7592

    FDA Recall
    Terminated ·Guidant Corp-Cpi Division·Product code DQR·March 11, 2004