74 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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
QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400, Manufactured for QRS Diagnostic, 14755 27th Ave North, Plymouth, MN 55447 USA. Product Usage: The Universal ECG is an Electrocardiograph Diagnostic System designed to provide measurements and interpretative statements of a patients ECG waveform. The interpreted ECG with measurements and diagnostic statements are provided to the physician on an advisory basis only, for the physician to over read and validate or change the ECG interpretation. The ECG measurements and interpretive statements may be reviewed, edited, distributed electronically or printed. No real time monitoring or alarm capability is provided.
FDA Recall
Terminated
·Qrs Diagnostic·Product code LOS·February 16, 2012
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 Recall
Terminated
·Product code HTT·May 11, 2017
CBS micro, countersink, cannulated, AO, Item Number 503004541
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019
CBS high, countersink, cannulated, AO, Item Number ST503004542
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019
CBS micro, countersink, cannulated, AO, Item Number ST503004541
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019
CBS 7.5 tap, cannulated, AO, Item Number 503002041
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWX·April 8, 2019
CBS high, countersink, cannulated, AO, Item Number 503004542
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019
CBS 4.0 countersink, cannulated, 30mm stop, AO, Item Number 503004353
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019
CBS micro, countersink, cannulated, round-shaft, Item Number 503004341
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019
CBS high, countersink, cannulated, round-shaft, Item Number 503004342
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019
CBS 4.0 countersink, cannulated, 15mm stop, AO, Item Number 503004352
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019
CBS 4.5 countersink, cannulated, 18mm stop, round-shaft, Item Number 503004351
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019
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
Kion Anesthesia Workstation Maquet Critical Care AB SE-171-95 Solna, Sweden
FDA Recall
Terminated
·MAQUET Inc.·Product code BSZ·July 10, 2007
Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. The Safety Alert action targets customers with Unit Serial numbers 24578 and lower. Manuf. Maquet Critial Care AB, SE-171 95 Solna, Sweden.
FDA Recall
Terminated
·Maquet Inc·Product code CBK·January 3, 2005
Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imaging System utilizing the auto-registration (fiducial- less) workflow used in combination during a DBS (deep brain stimulation) procedure. Neurological stereotaxic Instrument.
FDA Enforcement
Class I
·Terminated·Medtronic Navigation, Inc.·May 27, 2020
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 Recall
Terminated
·Product code LXH·June 27, 2016
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