3 results
·
6ms
·
Sources: EU EUDAMED, US FDA
PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner. This device is not intended for home use.
FDA Enforcement
Class II
·Terminated·Gsi Group Inc·March 2, 2016
SEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System is a self-contained dental delivery system with a built-in air compressor,vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced Dental System can also be upgraded to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in a holder along side the other handpiece connections. The Micadent is used to perform intra¿ oral air abrasion procedures including etching and preparing surfaces for composite restoration. The SEAC Advanced Dental System is substantially similar in design and functions as the SEAC Mobile Dental System manufactured by ASI Medical, Inc. The Micadent is manufactured by Medidents and will be supplied to ASIas a completed product. The Micadent is substantially the same as it is provided and is attached to an accessory air line inside the SEAC unit for operation. It is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law.
FDA Enforcement
Class II
·Terminated·ASI Medical, Inc.·December 25, 2013
Pathfast D-Dimer, Reference number: PF1051-KUS
FDA Enforcement
Class II
·Terminated·Lsi Medience Corporation·November 30, 2016