71 results
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17ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
FDA Recall
Open, Classified
·Micro-X Ltd. A14 6 MAB Eastern Promenade Tonsley Australia·Product code IZL·August 31, 2022
Cios care fusion system
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·June 20, 2019
Cios Alpha VA20/ VA30 mobile X-Ray systems
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·June 20, 2019
Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology, interventional radiology, and interventional neuroradiology.
FDA Recall
Completed
·Shimadzu Medical Systems·Product code OWB·November 4, 2019
The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The GE OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures.
FDA Recall
Open, Classified
·Ge Healthcare·Product code RCC·May 8, 2020
FDP Plasma kit provides reagents for the detection and semi-quantitation of fibrin/fibrinogen degradation products (FDP) in plasma through the use of latex particles coated with monoclonal antibodies to FDP. The kit contains: 1 x1.3 mL vial of Reagent 1 (Latex), 1 x 20mL bottle of Reagent 2 (Buffer), 1 x 0.5mL vial of Reagent 3 (Negative Control), 1 x 0.5mL vial of Reagent 4 (Positive Control) and 10 test cards with mixing rods packaged in a predominantly white cardboard unit container. Distributed in the USA by Diagnostica Stago, Five Century Drive, Parsippany, NJ 07054.
FDA Recall
Terminated
·Diagnostica Stago, Inc.·Product code DAP·December 4, 2002
Product: STA Liatest D-Di; REF: 00515;
FDA Recall
Open, Classified
·Diagnostica Stago, Inc.·Product code DAP·September 12, 2025
Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens.
FDA Recall
Terminated
·Alere San Diego, Inc.·Product code DAP·May 22, 2012
Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDMR CalPak), Catalog No. CDDMR-C is an in-vitro diagnostic product intended to be used for the calibration of the Stratus(R) CS Acute Care(TM) D-dimer )DDMR) method
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code DAP·June 7, 2012
Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13.
FDA Recall
Terminated
·Dade Behring Inc. Rte 896, Glasgow Business Community·Product code DAP·December 3, 2004
Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA - Liatest D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R, STA Compact and STA Satellite analyzers by professional laboratory personnel. The STA - Liatest D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: No
FDA Recall
Open, Classified
·Diagnostica Stago, Inc.·Product code DAP·February 5, 2026
Stratus CS STAT Fluorometric Analyzer DDMR TestPak (CDDMR) in vitro diagnostic.
FDA Recall
Terminated
·Dade Behring Inc.·Product code DAP·April 3, 2006
VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products in human plasma using the Enzyme Linked Fluorescent Assay technique. Also indicated for use in conjunction with clinical pretest probability assessment model to exclude DVT and PE disease.
FDA Recall
Terminated
·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code DAP·April 17, 2013
D-Dimer Test
FDA Recall
Open, Classified
·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code DAP·November 3, 2025
VIDAS DEX@, Dimer Exclusion II, REF 30455-01
FDA Recall
Open, Classified
·bioMerieux, Inc.·Product code DAP·September 22, 2021
Stratus CS STAT Fluorometric Analyzer DDMR DilPak (CDDMR-D) in vitro diagnostic.
FDA Recall
Terminated
·Dade Behring Inc.·Product code DAP·April 3, 2006
Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method.
FDA Recall
Terminated
·Dade Behring Inc.·Product code DAP·July 29, 2005
Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in vitro diagnostic
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code DAP·November 11, 2015
aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
FDA Recall
Terminated
·AAP Implantate Ag Lorenzweg 5 Berlin Germany·Product code GAD·November 28, 2019
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 Recall
Terminated
·AAP Implantate Ag Lorenzweg 5 Berlin Germany·Product code KDG·January 11, 2019