BEUDAMED
    18 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box); 2. Sprotte 22G x 120mm w/ introducer and wings (25/box); 3. Sprotte 19G x 90mm w/ introducer and wings (25/box]); 4. Sprotte 22G x 103mm w/ introducer and wings (25/box); 5. Sprotte 21G x 90mm w/ introducer and wings (25/box); 6. Sprotte 21G x 103mm w/ introducer and wings (25/box); 7. Sprotte 20G x 103mm w/ introducer and wings (25/box); 8. Sprotte 20G x 90mm w/ introducer and wings (25/box) Product Usage: The SPROTTE¿ lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/ discography procedures. The device is intended for adult and pediatric patients.

    FDA Enforcement
    Class II ·Ongoing·Pajunk GmbH·November 6, 2019

    Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;

    FDA Enforcement
    Class II ·Ongoing·New Medical Technologies Gmbh·February 12, 2025

    Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;

    FDA Enforcement
    Class II ·Ongoing·New Medical Technologies Gmbh·February 12, 2025

    Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080

    FDA Enforcement
    Class II ·Ongoing·New Standard Device Inc·September 7, 2022

    Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A

    FDA Enforcement
    Class II ·Ongoing·New Standard Device Inc·June 29, 2022

    'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805

    FDA Enforcement
    Class II ·Ongoing·New Standard Device Inc·June 21, 2023

    namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468; 2) MTS,RIGHT HEART,KIT,W/TRANS,ST. *, REF 60010511; 3) MTS,LT,HT,KIT-BRYAN,LGH,M.C.,EAST, REF 60020323; 4) MTO,RIGHT,KIT-BRONSON,M* HOSP PG, REF 60020676; 5) MTS,LEFT HEART,KIT-C*,MEM HLTHCARE, REF 60035977; 6) MTS,LEFT HEART,KIT,J*,M*,C*, REF 60040273; 7) MTS,LEFT HEART,KIT,C*,C*, REF 60100313; 8) MTS,3V,KIT-M*,MEMORIAL, REF 60131208; 9) MTS,3V,KIT-M*,MEMORIAL, REF 60131208; 10) MTO,LEFT HEART,KIT,-,N* HOSPITAL PG, REF 60140101; 11) MTO,LEFT HEART,KIT,-,N* HOSPITAL PG, REF 60140101; 12) MTS,LEFT HEART,MAN,KIT,S*-BALTIMORE, REF 60190947; 13) MTS-LEFT HEART,KIT-W*,H* HOSP PG, REF 60231052; 14) MTO,3-VALVE,KIT-T*,A*-PG, REF 65190182; 15) MTO,LEFT HEART,KIT,-,S* F*,-,PG, REF 65190474; 16) MTS,DR.,MCKAYS,4V,KIT,-,H* HOSP PG, REF 600800516; 17) MTS,EP,KIT,-,S*,TEACHING HOSPITAL PG, REF 601309013; 18) MTS,RHT,HRT-S* HOSP &,MC, REF 601905413; 19) MTS,PEDS,LFT,&,RT,HRT-S* HOSP, REF 601905414; 20) MTO,SCH,BEL,J*,H*-ST-PAUL,-,PG, REF 606604328; 21) LHK,-,MID,3VCOMP,OFF,PS,S10RA, REF 613000122; 22) MTS,LHK,W* HOSPITAL, REF 6010034281; 23) MTS,LHK,W* HOSPITAL, REF 6010034281; 24) MTS,LHK,P*,P* MED CTR, REF 6010171931; 25) MTS,LHK,M* HEALTHCARE,MGMT, REF 6061073001; 26) TVR US B* INTEGRATED SERVICE CENT, REF 601316711A; 27) LHK-S* MEDICAL CENTER,A*, REF 60190776A; 28) LHK,-,S*,AND,W* HOSPITAL, REF 60191118A.

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 2, 2025

    Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723

    FDA Enforcement
    Class II ·Ongoing·Fisher & Paykel Healthcare, Ltd.·October 22, 2025

    Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;

    FDA Enforcement
    Class II ·Ongoing·Adept Medical Ltd·January 29, 2025

    Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;

    FDA Enforcement
    Class II ·Ongoing·Adept Medical Ltd·January 29, 2025

    PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities.

    FDA Enforcement
    Class II ·Ongoing·Fisher & Paykel Healthcare, Ltd.·October 2, 2024

    Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US

    FDA Enforcement
    Class II ·Ongoing·Fisher & Paykel Healthcare, Ltd.·May 22, 2024

    Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;

    FDA Enforcement
    Class II ·Ongoing·Adept Medical Ltd·January 29, 2025

    Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;

    FDA Enforcement
    Class II ·Ongoing·Adept Medical Ltd·January 29, 2025

    Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;

    FDA Enforcement
    Class II ·Ongoing·Adept Medical Ltd·January 29, 2025

    Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;

    FDA Enforcement
    Class II ·Ongoing·Adept Medical Ltd·January 29, 2025

    Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;

    FDA Enforcement
    Class II ·Ongoing·Adept Medical Ltd·January 29, 2025

    Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;

    FDA Enforcement
    Class II ·Ongoing·Adept Medical Ltd·January 29, 2025