27 results
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11ms
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Sources: EU EUDAMED, US FDA
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
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
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
Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
FDA Enforcement
Class II
·Terminated·Medtronic Neuromodulation·May 27, 2015
Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
FDA Enforcement
Class II
·Terminated·Advanced Neuromodulation Systems Inc.·March 6, 2013
Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
FDA Enforcement
Class II
·Terminated·Medtronic Neuromodulation·August 31, 2016
Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws, round-shaft The Countersink is an instrument which is used over the guide wire to prepare for adequate space in the cortical bone rim to sink the screw head in to bones/tissues for different Foot, Ankle and Hand implant systems. The instrument is used in several Normed implant systems. The instrument is used to avoid soft tissue irritation
FDA Enforcement
Class II
·Terminated·Zimmer Gmbh·May 24, 2017
TWIST D 28X150MM CBS 45 Cann 14 MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
FDA Enforcement
Class II
·Terminated·Zimmer Gmbh·August 10, 2016