20 results
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24ms
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Sources: EU EUDAMED, US FDA
Workflow Box
FDA 510(k)
FDA Class 2
·Radiology
THE OPTIC BOX CONTACT LENS CASE
FDA 510(k)
FDA Class 2
·Ophthalmic
Caphosol® Artifical Saliva (32 doses sachet box)
FDA 510(k)
FDA Unclassified
·Unknown
KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100
FDA 510(k)
FDA Class 2
·Ophthalmic
HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8
FDA Enforcement
Class II
·Terminated·Huntleigh Healthcare Ltd.·April 27, 2022
Trial Tampon Box; Model Number: FG-TMP-REF04050504;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
FDA Enforcement
Class II
·Terminated·Vascutek, Ltd.·July 8, 2015
Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
FDA Enforcement
Class II
·Terminated·Vascutek, Ltd.·July 8, 2015
VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is labeled with a barcode label. The label should include the name of the reagent, a barcode, lot information and expiry dating.
FDA Enforcement
Class III
·Terminated·ORTHO-CLINICAL DIAGNOSTICS·June 10, 2015
McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items, each individually peel-pouched and EtO sterilized. Product Usage: Single Use, sterile video laryngoscope blade for use with McGRATH MAC Video Laryngoscopes
FDA Enforcement
Class II
·Terminated·Aircraft Medical Limited·December 10, 2014
IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalcin Control Set is used for quality control of the IDS-iSYS N-Mid¿ Osteocalcin Assay on the IDS-iSYS Multi-Discipline Automated Analyser.
FDA Enforcement
Class II
·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012
IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) assay is intended for the quantitative determination of intact PINP in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser.
FDA Enforcement
Class II
·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012
IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) Control Set is used for quality control of the IDS-iSYS Intact PINP 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) 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
IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalcin Assay is intended for the quantitative determination of Osteocalcin 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 assist the clinician. Osteocalcin is an indicator of osteoblastic activity in human serum and plasma and is intended to be used as an aid in the prevention of osteoporosis.
FDA Enforcement
Class II
·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012
IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. The Urine BETA CrossLaps¿ ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type-I collagen in human urine. The Urine BETA CrossLaps¿ ELISA assay is intended for in vitro diagnostic use as an indication of human bone resorption as an aid in A. Monitoring bone resorption changes of 1) Anti-resorptive therapies in postmenopausal women: a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies B. Predicting skeletal response (Bone Mineral Density) in postmenopausal women undergoing anti-resorptive therapies a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies
FDA Enforcement
Class II
·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012
Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company
FDA Enforcement
Class II
·Terminated·Vascutek, Ltd.·August 27, 2014