18 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MI View&GO
FDA 510(k)
FDA Class 2
·Radiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517570987·CoRoent Ant TLIF Ti, 14x12x30mm 0°
NA
FDA UDI
Medos International Sàrl·10886705026180·OVB1 HD Camera Control Unit Contents also inclu...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702404203·Elvarex 2/Thigh High/Open Toe, E-Version, Knee ...
Evolve Template 35.5mm Size 1
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215074494·
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE INC.·Product code LZG·March 9, 2015
AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Arrow GPSCath Balloon Dialation Catheter (150 cm)
FDA 510(k)
FDA Class 2
·Cardiovascular
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·December 11, 2020
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·November 11, 2014
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·September 10, 2011
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·July 23, 2013
OVB1 CAMERA CONTROL UNIT
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code FWF·March 18, 2019
Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
FDA Recall
Terminated
·JAS Diagnostics Inc.·Product code GKZ·April 21, 2017
The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results are reported in ELISA units (EU) per ml determined by comparison to a Calibrator.
FDA Recall
Terminated
·Diamedix Corporation·Product code LLL·August 6, 2012
Is-anti-Gliadin IgG Enzyme Immunoassay Test Kit packaged in cardboard boxes with individual components secured within a foam insert. Catalog Number # 720-800. - Laboratory In-Vitro Diagnostic Assay intended for the semi-quantitative detection of IgG antibodies to Gliadin in human serum by indirect enzyme immunoassay as an aid in the diagnosis of celiac disease.
FDA Recall
Terminated
·Diamedix Corporation·Product code MST·March 21, 2008
Product is labeled in part: "***is immunosimplicity***ENA-6 Screen***Enzyme Immunoassay Test Kit***Catalog No: 720-230***Exp. Date: 2012-05-31***Contains Sufficient for 96 Tests***C - Corrosive Harmful***Lot No: S0000***For In Vitro Diagnostic Use***Caution, consult accompanying documents***Manufacturer DIAMEDIX***a Subsidiary of IVAX Diagnostics, Inc.***Miami, FL 33127 USA-1-800-327-4565***Biohazard***" For the qualitative screening of human IgG antibodies to extractable nuclear antigens (ENA) in human serum by indirect enzyme immunoassay as an aid in the diagnosis of certain autoimmune disorders. This test system screens for antibodies to Sm, Sm/RNP, SSA, SSB, Scl-70 and Jo-1 in one well. Positive samples should be evaluated further using tests designed for each ENA antibody.
FDA Recall
Terminated
·Diamedix Corporation·Product code LLL·June 8, 2011
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Azurion 7 B20, Model Number 722068. 5. Azurion 7 M12, Model Number 722078. 6. Azurion 7 M20, Model Number 722079. 7. Azurion 3 M12, Model Number 722221. 8. Azurion 3 M15, Model Number 722222. 9. Azurion 7 M12, Model Number 722223. 10. Azurion 7 M20, Model Number 722224. 11. Azurion 7 B12, Model Number 722225. 12. Azurion 7 B20, Model Number 722226. 13. Azurion 5 M12, Model Number 722227. 14. Azurion 5 M20, Model Number 722228. 15. Azurion 7 M20, Model Number 722282.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025