436 results
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7ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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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
GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 29, 2012
Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
FDA Enforcement
Class II
·Ongoing·Brasseler USA I Lp·February 14, 2024
Hobbs Medical Polypectomy Snare, Catalog No. 7202
FDA Enforcement
Class II
·Ongoing·Hobbs Medical, Inc.·July 27, 2022
The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.
FDA Enforcement
Class II
·Terminated·Bio-Rad Laboratories·September 26, 2012
VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·January 1, 2014
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·January 31, 2024
VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - green, C2 - yellow, C3 - red).
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·June 19, 2024
Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·June 12, 2019
K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine.
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·August 21, 2019
K-Wire HBS Sterile Lot, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
FDA Enforcement
Class II
·Terminated·BioPro, Inc.·August 21, 2019
ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025
Offset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems. Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems
FDA Enforcement
Class II
·Terminated·Omnilife Science Inc.·September 2, 2015
Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
FDA Enforcement
Class II
·Terminated·Conformis, Inc.·June 19, 2019
Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
FDA Enforcement
Class II
·Terminated·Conformis, Inc.·June 19, 2019
iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
FDA Enforcement
Class II
·Terminated·Conformis, Inc.·October 16, 2019
iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
FDA Enforcement
Class II
·Terminated·Conformis, Inc.·October 16, 2019
.045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter. .054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407ST and has a 7 inch length and 0.054 inch diameter. These guide wires are an orthopedic manual surgical instrument.
FDA Enforcement
Class II
·Terminated·Acumed LLC·March 22, 2017
Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·April 4, 2018
50 mm Screw, Item #BG7050 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
FDA Enforcement
Class II
·Terminated·Spinal Solutions, LLC·June 5, 2013