28 results
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11ms
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Sources: EU EUDAMED, US FDA
The D*Clot HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The disposable system consists of an outer sheath through which a rotatable radiopaque spiral shaft extends ending in an eccentric blunt distal tip. Once activated, the shaft rotates at approximately 10.000 RPMs to break thrombus into smaller particles, which can be simultaneously aspirated using a dedicated vacuum syringe. The catheter is a stand-alone system and is powered by a 4.5 VDC alkaline battery pack in the control unit.
FDA Recall
Open, Classified
·Mermaid Medical A/S Frydensbergvej 25 Stenlose Denmark·Product code QEW·May 1, 2024
ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
FDA Recall
Open, Classified
·Inari Medical Oak Canyon·Product code QEW·July 19, 2024
Artix MT Thrombectomy Device, REF: 32-102
FDA Recall
Open, Classified
·Inari Medical Oak Canyon·Product code QEW·April 8, 2025
Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL
FDA Recall
Open, Classified
·Product code KIE·October 9, 2024
BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions.
FDA Recall
Open, Classified
·Straight Smile, LLC·Product code NXC·November 4, 2024
Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080
FDA Recall
Open, Classified
·New Standard Device Inc·Product code KTT·December 28, 2020
'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
FDA Recall
Open, Classified
·New Standard Device Inc·Product code KTT·July 23, 2019
Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
FDA Recall
Open, Classified
·New Standard Device Inc·Product code HXC·August 14, 2019
Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems, Catalog Number A16972
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code CEW·November 26, 2024
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
FDA Recall
Open, Classified
·Future Diagnostics Solutions B.V. Nieuweweg 279 Wijchen Netherlands·Product code CEW·December 6, 2022
Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma.
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code CEW·November 8, 2024
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry.
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code DEW·July 31, 2024
Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CEW·September 22, 2025
VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) Catalog Number: 6802892
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code CEW·November 17, 2022
Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
FDA Recall
Open, Classified
·New Medical Technologies Gmbh Wankdorffeldstrasse·Product code GEH·December 19, 2024
Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
FDA Recall
Open, Classified
·New Medical Technologies Gmbh Wankdorffeldstrasse·Product code GEH·December 19, 2024
Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)
FDA Recall
Open, Classified
·Given Imaging Ltd. New Industrial Park·Product code FFT·June 3, 2025
Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
FDA Recall
Open, Classified
·Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Place East Tamaki Auckland New Zealand·Product code BTT·April 2, 2024
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
FDA Recall
Open, Classified
·Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Place East Tamaki Auckland New Zealand·Product code BTT·September 18, 2025
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities.
FDA Recall
Open, Classified
·Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Place East Tamaki Auckland New Zealand·Product code QAV·August 7, 2024