106 results
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12ms
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Sources: EU EUDAMED, US FDA
Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime CCS Comp Analyzer with Scanner PN 52857 Stat Profile Prime CCS Comp Analyzer Blood Gas/Electrolyte/Metabolite/CO-Oximetry Analyzer
FDA Enforcement
Class II
·Terminated·Nova Biomedical Corporation·July 19, 2017
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 3, 2017
Series OEC 9800. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient,during diagnostic, surgical and interventional procedures.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·November 19, 2014
NDI P7 Position Sensor, Stereotaxic Instrument
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 17, 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
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
Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation installed with the CAS I/II Absorber. Anesthesia workstation for use in the hospital environment and locations not requiring portability.
FDA Enforcement
Class I
·Terminated·Del Mar Reynolds Medical, Ltd.·March 27, 2013
CBS 4.5 countersink, cannulated, 18mm stop, round-shaft, Item Number 503004351
FDA Enforcement
Class II
·Terminated·Zimmer GmbH·May 29, 2019
OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile c arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical, orthopedic, and extremity imaging. The device is not intended for whole body pediatric imaging.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 8, 2012
UroView 2800; MDL number A349855. Product Usage: Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical application may include but are not limited to urologic and endoscopic procedures. The system may be ued for other imaging applications at the physician's discretion.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 8, 2012
OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 8, 2012
Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
FDA Enforcement
Class II
·Terminated·Zimmer CAS·June 10, 2015
Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
FDA Enforcement
Class III
·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 24, 2017