BEUDAMED
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    Femoral Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 2017

    The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·March 4, 2015

    6 cm Catheter Reservoir with 10 cm extension

    FDA Recall
    Terminated ·Vygon Neuro·Product code HCA·March 24, 2005

    Cranial Access Kit (INS-HITH) included in External CSF Drainage Kit convenience Kit #31176. The kit contains: one Hermetic Large Style Ventricular Catheter Set, one Ventricular Drainage System, one INS-HITH Cranial Access Kit, one Sodium Chloride 10 ml, and one Suture 2-0 silk.

    FDA Recall
    Terminated ·Integra Life Sciences Corp.·Product code HCA·March 19, 2003

    Codman Holter Salmon Rickham Reservoir with Ventricular Catheter Catalog Number: 82-1617

    FDA Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code HCA·March 11, 2004

    7 cm Catheter Reservoir with 10 cm extension

    FDA Recall
    Terminated ·Vygon Neuro·Product code HCA·March 24, 2005

    10 cm Scopable Catheter Reservoir

    FDA Recall
    Terminated ·Vygon Neuro·Product code HCA·March 24, 2005

    CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephalus. Catalog Number: NS5524

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HCA·March 17, 2021

    Cannulaide, Model 101. The Cannulaide product is composed of die-cut hydrocolloid coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface. The Cannulaide is applied under and over the nose of infants to provide a protective barrier to the philtrum, columella, septum, nares, and tip of nose. It is available in multiple sizes that vary the external geometry and nare hole size and spacing to allow for use on infants ranging from less than 700 grams to greater than 3000 grams. It is a non sterile, single patient use, disposable device.

    FDA Recall
    Terminated ·Beevers Manufacturing & Supply, Inc.·Product code BZD·January 18, 2007

    DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and 30108C INT. This assay provides only a preliminary analytical test result.

    FDA Recall
    Terminated ·Express Diagnostics Int'l., Inc.·Product code MGX·November 21, 2014

    DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and 30108C INT. This assay provides only a preliminary analytical test result.

    FDA Enforcement
    Class II ·Terminated·Express Diagnostics Int'l., Inc.·February 11, 2015

    AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK-42703-P1A; (2) AK-45703-P1A; (3) AK-45703-PB1A; AGB+ Pressure Injectable Multi-Lumen CVC Kit (4) CA-42703-P1A; (5) CA-42854-P1A; (6) CA-45703-P1A; AGB+ Pressure Injectable Quad-Lumen CVC Kit (7) CA-45854-P1A; (8) CDA-42703-P1A; AGB+ Quad-Lumen CVC Kit (9) AK-42854-P1A; (10) AK-45854-P1A; AGB+ Two Lumen CVC Kit (11) AK-42802-P1A; (12) AK-45802-P1A; (13) AK-46702-P1A; (14) AK-47702-P1A; ARROWg+ard BLUE PLUS Pressure Injectable Multi-Lumen CVC Kit (15) CDA-45703-P1A; ARROWg+ard BLUE PLUS Pressure Injectable Quad-Lumen CVC Kit (16) CDA-45854-P1A; ARROWg+ard BLUE PLUS Pressure Injectable Two-Lumen CVC Kit (17) CDA-22122-U1A; (18) CDA-42802-P1A; (19) CDA-42854-P1A; (20) CDA-47702-P1A; ARROWg+ard Blue¿ MAC" Two-Lumen CVC Access Kit (21) CDA-21242-1A; ARROWg+ard Blue¿ PSI Kit (22) CDA-29803-1A; ARROWg+ard Blue¿ Two-Lumen CVC Kit (23) AK-22702-P1A; ARROWg+ard Blue¿ You-Bend" Two- Lumen Hemodialysis Catheterization Kit for High Volume Infusions (24) CDA-25122-U1A; Multi-Lumen CVC Kit with Blue FlexTip(R) Catheter and Sharps Safety Features (25) ASK-12703-PRJ; (26) ASK-15703-PRJ; Multi-Lumen Pressure Injectable Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features (27) ASK-45703-PRH; Pressure Injectable ARROWg+ard Blue Plus(R) Multi-Lumen CVC Kit (28) ASK-45703-PRWJ1; Pressure Injectable ARROWg+ard Blue PLUS(R) Quad-Lumen CVC Kit (29) ASK-42854-PRJ; Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central CVC Kit (30) ASK-47702-PPHP; Pressure Injectable ARROWg+ard Blue PLUS(R)Multi-Lumen CVC Kit (31) ASK-45703-PUCD; Pressure Injectable Multi-Lumen CVC Kit (32) ASK-12703-PCA; (33) ASK-15703-PCA; (34) ASK-15703-PHH; (35) ASK-15703-PLV; Pressure Injectable Multi-Lumen CVC kit with Blue Flex Tip¿, ARROWg+ard Blue PLUS¿ Catheter and Sharps Safety Features (36) ASK-42703-PBM; (37) ASK-15703-PRH; (38) ASK-15703-PRWJ; (39) ASK-42703-PRJ; (40) ASK-45703-PRJ; Pressure Injectable Quad-Lumen CVC Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions (41) ASK-42854-PNMM; Pressure Injectable Two Lumen CVC Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features (42) ASK-42802-PBM

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·April 18, 2018

    Codman 1/4 x 1/4" Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1399

    FDA Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code HBA·July 16, 2010

    American Surgical Delicot 20 mm x 60 mm Ref Number: 63-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Recall
    Terminated ·American Surgical Company·Product code HBA·March 31, 2016

    American Surgical Telfa 1/2" x 3" Ref Number: 80-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Recall
    Terminated ·American Surgical Company·Product code HBA·March 31, 2016

    American Surgical Policot 1/2" x 1.5" Ref Number: 90-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Recall
    Terminated ·American Surgical Company·Product code HBA·March 31, 2016

    American Surgical Delicot 10 mm x 13 mm Ref Number: 63-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Recall
    Terminated ·American Surgical Company·Product code HBA·March 31, 2016

    American Surgical Ray-Cot 1/4" x 3" Ref Number: 60-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Recall
    Terminated ·American Surgical Company·Product code HBA·March 31, 2016

    American Surgical Delicot non-xray 5 mm x 13 mm Ref Number: 63-02 non-xray Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Recall
    Terminated ·American Surgical Company·Product code HBA·March 31, 2016

    American Surgical Policot 1/2" x 1/2" Ref Number: 90-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Recall
    Terminated ·American Surgical Company·Product code HBA·March 31, 2016