60 results
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6ms
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Sources: EU EUDAMED, US FDA
North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial x-ray imaging of product hardware
FDA Enforcement
Class II
·Ongoing·North Star Imaging Inc·November 15, 2017
Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. The NSI Implant System is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
FDA Enforcement
Class II
·Terminated·Southern Implants, Inc·December 4, 2013
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
ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22U
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22V
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
HAND PACK-Procedure Kit Catalog Number: WEHD16C
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
KNEE ARTHROSCOPY-Procedure Kit Catalog Number: QPKA35A
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
KNEE ARTHROSCOPY PACK Catalog Number: MEKA12R
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
TOTAL KNEE -Procedure Kit Catalog Number: QPTK95B
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
TOTAL KNEE, ST LUKES Catalog Number: LMTK17AP
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
KNEE ARTHROSCOPY-Procedure Kit Catalog Number: SLAR14G
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10L
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
HAND PACK 297829--Procedure Kit Catalog Number: RGHN04I
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
KNEE SCOPE Procedure tray Catalog Number: COKN48L
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
TOTAL KNEE - 247546 - Procedure tray Catalog Number: BFTK01AA
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
TOTAL KNEE -Procedure Kit Catalog Number: QPTK95A
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AA
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024