10,000 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PALLAS M/MAXIMIS 45mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
FDA Enforcement
Class II
·Terminated·Valorem Surgical LLC·August 16, 2017
PALLAS M/MAXIMIS Poly Screw Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
FDA Enforcement
Class II
·Terminated·Valorem Surgical LLC·August 16, 2017
PALLAS M/MAXIMIS 7.5 x 45mm screw and 7.5 x 4.5 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
FDA Enforcement
Class II
·Terminated·Valorem Surgical LLC·August 16, 2017
TransMotion Medical, TMM5 Series Mobile Surgical Stretcher -Chair. Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient environment.
FDA Enforcement
Class II
·Terminated·Winco Mfg., LLC·October 19, 2016
Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use- Sterile Single Use Only Product Code 400-009
FDA Enforcement
Class II
·Terminated·Banyan Medical, LLC·October 19, 2016
TransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair. Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient environment.
FDA Enforcement
Class II
·Terminated·Winco Mfg., LLC·October 19, 2016
Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80072-F Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle or a catheter inserted into a vein.
FDA Enforcement
Class II
·Terminated·Zyno Medical LLC·October 5, 2016
GE Healthcare Optima CT520 X-ray system
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 21, 2017
OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·April 22, 2015
GE Healthcare Discovery Ml X-ray system
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 21, 2017
Conical EP Twist Lock TM Coping Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
Certain Pick-up Coping Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
Locator Replacement Males 4pk Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
Locator Replacement Housing Kit Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
Certain Gingihue Post 5mm(D) x 5mm(P) x 2mm(H) Item: IWPP552G Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
Provide Impression Coping Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
Certain Pick-Up Coping 4.1mm(D) x 5mm(P) Item: IIIC12 Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
Conical 17 degree Angled Abutment Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
Certain Straight Pick Up Coping Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
Preformance 15 degrees pre-angled post Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016