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

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    Filters Classification: Class Ii ×

    Intubation Scope Intended to provide optical visualization of, therapeutic access to, and use to facilitate routine or difficult tracheal intubations of the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx and Trachea. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 6, 2016

    Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S

    FDA Enforcement
    Class II ·Ongoing·EMPATICA SRL·November 1, 2023

    Ureteroscope Intended to provide optical visualization of and therapeutic access to the Urinary Track. This anatomy includes but is not restricted to the organs, tissues and subsystems: Urethra, Bladder and Renal Pelvis. The instrument is introduced via the urethra when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 6, 2016

    DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to multiple accessories used in DBS lead implant procedures. Among these accessories is the DBS lead holder, also referred to as the lead depth stop. The lead holder affixes to the DBS lead during the lead implant procedure, marking the distance to the lead tip and providing control of DBS lead depth during implant by interfacing with the stereotactic system

    FDA Enforcement
    Class II ·Terminated·Medtronic Neuromodulation·August 30, 2017

    CBS micro, countersink, cannulated, AO, Item Number ST503004541

    FDA Enforcement
    Class II ·Terminated·Zimmer GmbH·May 29, 2019

    CBS high, countersink, cannulated, AO, Item Number ST503004542

    FDA Enforcement
    Class II ·Terminated·Zimmer GmbH·May 29, 2019

    CBS high, countersink, cannulated, AO, Item Number 503004542

    FDA Enforcement
    Class II ·Terminated·Zimmer GmbH·May 29, 2019

    CBS 7.5 tap, cannulated, AO, Item Number 503002041

    FDA Enforcement
    Class II ·Terminated·Zimmer GmbH·May 29, 2019

    CBS micro, countersink, cannulated, AO, Item Number 503004541

    FDA Enforcement
    Class II ·Terminated·Zimmer GmbH·May 29, 2019

    DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010

    FDA Enforcement
    Class II ·Terminated·Perkinelmer·January 23, 2013

    CBS micro, countersink, cannulated, round-shaft, Item Number 503004341

    FDA Enforcement
    Class II ·Terminated·Zimmer GmbH·May 29, 2019

    CBS high, countersink, cannulated, round-shaft, Item Number 503004342

    FDA Enforcement
    Class II ·Terminated·Zimmer GmbH·May 29, 2019

    CBS 4.0 countersink, cannulated, 30mm stop, AO, Item Number 503004353

    FDA Enforcement
    Class II ·Terminated·Zimmer GmbH·May 29, 2019

    CBS 4.0 countersink, cannulated, 15mm stop, AO, Item Number 503004352

    FDA Enforcement
    Class II ·Terminated·Zimmer GmbH·May 29, 2019

    Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·November 19, 2025

    Medline convenience kit: BHS NEURO DYNJ904900N MEDTRX NEURO PACK DYNJ67267B MRI DBS PACK DYNJ9814630O NEURO CDS-LF CDS983383L NEURO PACK DYNJ59397Q DYNJT7315 NEURO PACK-LF DYNJ25097I NEURO VP SHUNT/VAGAL NERVE-RF DYNJ21925S PK NEURO SHUNT BUMC DYNJT6428 RR-NEURO DBS HEAD PACK-LF DYNJ0785736M VP SHUNT SYNJ10307B

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·June 24, 2026

    St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY CE 0086 0123 St. Jude Medical Plano, TX St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 40 cm, 0.5 REF 6172 STERILE EO Rx ONLY St. Jude Medical Plano, TX Instructions For Use: Lead and Extension Kits for Deep Brain Stimulation Systems Clinician's Manual ST. JUDE MEDICAL - Product Usage: St. Jude Medical Deep Brain Stimulation (DBS)leads are intended to deliver stimulation to target areas in the brain. DBS extensions are intended to connect the leads to implantable pulse generators (IPGs). St. Jude Medical DBS leads are designed for introduction into the brain using standard stereotactic neurosurgical techniques. DBS system delivers electrical stimulation to a precisely targeted area in the brain. Leads are implanted in the brain and are connected to extensions, which are passed under the skin and are connected to the neurostimulator. Leads for the St. Jude Medical Infinity DBS System feature electrodes on a stiff distal end with an inactive lead tip. The proximal end of the lead contains contact bands that correspond with each of the distal electrodes and an inactive band that functions as a contact for a setscrew when connecting to a compatible extension. The 8-channel leads contain cylindrical and segmented electrodes. The segmented electrodes can be activated independently to focus stimulation in one direction to help target desired neurological structures. As stated in Clinician manual (ARTEN600008305 Rev A), leads materials which are intended to come into contact with tissue are Platinum-iridium and polycarbonate urethane. In addition, drawing for the Stim Tip, 1-3-3-1 Directional DBS lead requires that the electrode material shall be 90/10 Platinum Iridium.

    FDA Enforcement
    Class II ·Terminated·St. Jude Medical, Inc.·December 19, 2018

    CBS 4.5 countersink, cannulated, 18mm stop, round-shaft, Item Number 503004351

    FDA Enforcement
    Class II ·Terminated·Zimmer GmbH·May 29, 2019

    LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.

    FDA Enforcement
    Class II ·Completed·Medtronic Neuromodulation·November 8, 2023

    Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile

    FDA Enforcement
    Class II ·Terminated·Medtronic Neuromodulation·May 27, 2015