BEUDAMED
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    Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers & Description: A4402, 3F-40CM, SYNTEL RT-EMB; A4403, 3F-80CM, SYNTEL RT-EMB; A4404, 4F-40CM, SYNTEL RT-EMB; A4405, 4F-80CM, SYNTEL RT-EMB; A4406, 5F-80CM, SYNTEL RT-EMB; A4407, 6F-80CM, SYNTEL RT-EMB; A4408, 7F-80CM, SYNTEL RT-EMB; A4F00, 2F-60CM (PREM) SYNTEL CATHETER; A4F01, 2F-80CM, (PREM) SYNTEL CATHETER; A4F02, 3F-40CM, (PREM) SYNTEL CATHETER; A4F03, 3F-80CM, (PREM) SYNTEL CATHETER; A4F04, 4F-40CM, (PREM) SYNTEL CATHETER; A4F05, 4F-80CM, (PREM) SYNTEL CATHETER; A4F06, 5F-80CM, (PREM) SYNTEL CATHETER; A4F07, 6F-80CM, (PREM) SYNTEL CATHETER; A4F08, 7F-80CM, (PREM) SYNTEL CATHETER; CE0260ST, L2F-60CM PREM SYNTEL CATH; CE0280ST, L2F-80CM PREM SYNTEL CATH; CE0340ST, 3F-40cm (PREM) SYNTEL CATHETER; CE0380ST, 3F-80CM PREM SYNTEL CATH; CE0440ST, 4F-40CM PREM SYNTEL CATH; CE0480ST, 4F-80CM PREM SYNTEL CATH; CE0580ST, 5F-80CM PREM SYNTEL CATH; CE0680ST, 6F-80cm (PREM) SYNTEL CATHETER; CE0780ST, 7F-80CM PREM SYNTEL CATH; CE0340, 3F-40cm, SYNTEL RT-EMB; CE0380, 3F-80cm, SYNTEL RT-EMB; CE0440, 4F-40cm, SYNTEL RT-EMB; CE0480, 4F-80cm, SYNTEL RT-EMB; CE0580, 5F-80cm, SYNTEL RT-EMB; CE0680, 6F-80cm, SYNTEL RT-EMB; CE0780, 7F-80cm SYNTEL RT-EMB. BARD Embolectomy Catheters are indicated for the removal of emboli and thrombi from the peripheral arterial system. These devices consist of a catheter body with a latex-free balloon on the distal end and an inflation hub on the proximal end.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·October 3, 2012

    VKS Tibial Trial, Right/Left, Prep Guide; Model Number: 1214331, 1214332, 1214333, 1214334, 1214335: ( Model Number: 1214331 VKS Tibial Prep Guide, Right/Left, Size 1, Lot Code EM. 1 and EM.6; 1214332 VKS Tibial Prep Guide, Right/Left, Size 2 Lot Code EM.l and EM.6, 1214333 VKS Tibial Prep Guide, Right/Left, Size 3 Lot Code EM.1; 1214334 VKS Tibial Prep Guide, Right/Left, Size 4 Lot Code EM.5; 1214335 YKS Tibial Prep Guide, Right/Left, Size 5 Lot Code EM), Plus Orthopedics

    FDA Recall
    Terminated ·Plus Orthopedics USA·Product code JWH·November 27, 2006

    DMLC IV-ERGO - Beam shaping block for Radiation Therapy.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 11, 2013

    EM2 NC AEM Monitor (NON-COM)

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·June 23, 2003

    EM2+A NC AEM Monotor (NON-COM)

    FDA Recall
    Terminated ·Encision, Inc.·Product code GEI·June 23, 2003

    Boston Scientific BLUE MAX" 20 Balloon Dilatation Catheter, UPN M001125420 (BMQ/7-4/5.8/40, 12-542), M001125630(BMQ/9-8/5.8/40, 12-563) Made in Ireland, Ballybrit Business Park, Galway, Ireland Recommended for Percutaneous Transluminal Angioplasty of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code LIT·February 18, 2010

    Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemistry use. Sakura Finetek USA, Inc.

    FDA Enforcement
    Class II ·Terminated·Sakura Finetek USA Inc·June 18, 2014

    Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.

    FDA Enforcement
    Class II ·Terminated·EMG Technology Co., Ltd.·September 24, 2014

    Harleco May and Grunwald's Stain; 0.17% w/v; Methanol Solution UN1230; EMD Chemicals Inc. An Affilifate of Merck KGaA Damstadt, Germany; 480 South Democrat Road; Gibbstown, NJ 08027; 1 liter and 4 liter poly bottles

    FDA Recall
    Terminated ·EMD Chemicals Inc·Product code KQC·July 30, 2007

    Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals Inc., Gibbstown, NJ 08027 1-800-222-0342 Made in India. The product is a Class I, IVD dye and chemical stain for use in Hematology.

    FDA Recall
    Terminated ·EMD Chemicals Inc.·Product code KQC·April 4, 2011

    Anaerotest for microbiology Specification: Performance Test Anerobic: white within 4-6 hours; aerobic: blue with 20 minutes Merck KgaA 64271 Darmstadt, Germany 1.19034.0002 17.08.06 1 unit UPC 4 022536 667928

    FDA Recall
    Terminated ·EMD Chemicals Inc·Product code J·August 17, 2006

    Ethanol Standard, 1.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case.

    FDA Recall
    Terminated ·EMD Chemicals Inc·Product code LCH·December 13, 2002

    EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml; 1.0 mg Ethanol in 1 ml, 10 ampules; Item number 68991/95; in vitro diagnostic.

    FDA Recall
    Terminated ·EMD Chemicals Inc·Product code DNN·March 27, 2008

    Histochemical PAS (Periodic Acid Schiff) Reaction Set' Class I, IVD; Set of 4 bottles including Schiff Reagent 225 mL, Light Green SF Yellowish Stain 225 mL, Sodium Carbonate Solution 225 mL and Periodic Acid Solution 225 mL' EMD Chemicals, Inc. 480 S. Democrat Road, Gibbstown, NJ 08027 Each kit provides reagents sufficient for a maximum of 100 tests.

    FDA Recall
    Terminated ·EMD Chemicals Inc·Product code HZT·June 2, 2008

    Ethanol Standard, 0.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case. Item Number 68988/95

    FDA Recall
    Terminated ·EMD Chemicals Inc·Product code LCH·December 13, 2002

    Anaerotest;Microbiology , 50 test strips 1.15112 Store dry and tightly closed. Store at + 15 C to +25C Merck IVD 64271 Darmstadt, Germany

    FDA Recall
    Terminated ·EMD Chemicals Inc·Product code J·August 17, 2006

    Histochemical PAS (Periodic Acid Schiff) Reaction Set. in vitro diagnostic. Product size configuration: Set of 4 bottles including Schiff Reagent 225mL, Light Green SF Yellowish Stain 225mL, Sodium Carbonate Solution 225mL, and Periodic Acid Solution 225mL. Each kit provides reagents sufficient for a maximum of 100 tests.

    FDA Recall
    Terminated ·EMD Chemicals Inc·Product code KKS·July 25, 2006

    Papanicolaou Stain EA-50. Product size configurations: 1L, 4L, and 10L. Item Nos. 7062X/75, 7062X/85, and 7062X/86.

    FDA Recall
    Terminated ·EMD Chemicals Inc·Product code HZJ·December 13, 2002

    Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.

    FDA Recall
    Terminated ·EMG Technology Co., Ltd.·Product code JCX·August 3, 2014

    NEEDLEZAP, a battery operated needle destruction device. The product is labeled and marketed for use only in the law enforcement market or veterinary market.

    FDA Recall
    Terminated ·E Med Future Inc·Product code MTV·August 15, 2002