BEUDAMED
    77 results · 11ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    Burlington Medical, Caps.

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·November 13, 2013

    ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025

    Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·November 13, 2019

    Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for slow, continuous delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications directly into an intraoperative site or subcutaneously for post-operative pain management.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·July 17, 2013

    Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for slow, continuous delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications directly into an intraoperative site or subcutaneously for post-operative pain management.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·July 17, 2013

    IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A; MPRESSION CAP CONT 3.5MM, REF ZOCIMP3S; IMPRESSION CAP CONT 4.5MM ANG, REF ZOCIMP4A; IMPRESSION CAP CONT 4.5MM, REF ZOCIMP4S; IMPRESSION CAP,CONT,5.5MM, ANG, REF ZOCIMP5A; IMPRESSION CAP, CONT, 5.5MM, REF ZOCIMP5S; MPRESSION CAP, CONT, 6.5MM,ANG, REF ZOCIMP6A; IMPRESSION CAP, CONT, 6.5MM, REF ZOCIMP6S

    FDA Enforcement
    Class II ·Terminated·Zimmer Dental Inc·October 4, 2017

    ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025

    SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 6, 2025

    Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for slow, continuous delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications directly into an intraoperative site or subcutaneously for post-operative pain management.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·July 17, 2013

    ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025

    ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025

    ACE Trochanteric Nail System STER TROC END CAP STER TROC END CAP 5MM STER TROC END CAP 10MM STER TROC END CAP 15MM STER TROC END CAP 20MM STER TROC END CAP 25MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 4, 2018

    ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025

    See Luer Cap Set, MPC-130, set, administration, intravascular

    FDA Enforcement
    Class II ·Ongoing·Molded Products Inc·April 15, 2026

    Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric Infusion Device Device Listing: D020871 Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·July 3, 2013

    ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025

    Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems, Inc.·November 18, 2015

    ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025

    Maquet Getinge-BEQ-T 4917 Mercy Medical Versa-Pack Material: 709000368

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·June 5, 2019