124 results
·
14ms
·
Sources: EU EUDAMED, US FDA
ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
FDA Enforcement
Class II
·Completed·Implant Direct Sybron Manufacturing, LLC·January 15, 2020
ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
FDA Enforcement
Class II
·Completed·Implant Direct Sybron Manufacturing, LLC·January 15, 2020
4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
FDA Enforcement
Class II
·Completed·Acumed LLC·April 27, 2022
Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3S
FDA Enforcement
Class II
·Completed·Covidien Llc·January 6, 2021
Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3L
FDA Enforcement
Class II
·Completed·Covidien Llc·January 6, 2021
4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012
FDA Enforcement
Class II
·Completed·Acumed LLC·April 27, 2022
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122
FDA Enforcement
Class II
·Completed·Philips Ultrasound, LLC·January 7, 2026
ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
FDA Enforcement
Class II
·Completed·Materialise USA LLC·August 31, 2022
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
FDA Enforcement
Class II
·Completed·SAFE ORTHOPAEDICS LLC·August 31, 2022
VariCam
FDA Enforcement
Class II
·Completed·GE Healthcare, LLC·January 16, 2019
Discover VH/Millennium VG Nuclear Medicine Imaging System
FDA Enforcement
Class II
·Completed·GE Healthcare, LLC·January 16, 2019
Phleb Pack and Laser Phleb Pack - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015
Endovenous Kit, Endo Pack and Endovenous Laser Kit - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015
Vaginal Rejuvenation Pack - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015
Face Neck Pack - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015
Blepharoplasty Pack - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015
Suction Pack - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015
General Pack - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015
Pediatric Pack - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015
Open Pack - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015