11 results
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9ms
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Sources: EU EUDAMED, US FDA
IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP (IDS-iSYS BAP) Control Set is used for quality control of the IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Assay on the IDS-iSYS Multi-Discipline Automated Analyser.
FDA Enforcement
Class II
·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012
IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP Assay (IDS-iSYS BAP) is intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum or plasma on the IDS-iSYS Multi- Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of post menopausal osteoporosis and Pagets disease.
FDA Enforcement
Class II
·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012
MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.
FDA Enforcement
Class II
·Terminated·Diagnostic Hybrids, Inc.·May 16, 2018
¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
FDA Enforcement
Class II
·Terminated·Fujifilm Medical Systems U.S.A., Inc.·April 21, 2021
ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·June 13, 2018
aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
FDA Enforcement
Class II
·Terminated·AAP Implantate Ag·April 15, 2020
Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·November 23, 2016
aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support during orthopedic surgeries. If not otherwise specified, instruments are intended for multiple use.
FDA Enforcement
Class II
·Terminated·AAP Implantate Ag·March 27, 2019
The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating subcutaneous fatty tissue in patients desiring aesthetic body contouring and autologous fat collection.
FDA Enforcement
Class II
·Terminated·Miami Fat Supply, Inc·June 22, 2016
CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.
FDA Enforcement
Class II
·Terminated·LAP of America Laser Applications, LLC·June 11, 2014
LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi projection format that defines isocenters, field and MLC contours along with a 3D patient view.
FDA Enforcement
Class II
·Terminated·LAP of America Laser Applications, LLC·July 2, 2014