11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELECTROSURGICAL AND ARTHROSCOPY ACCESSORY ELECTRODES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Freedom Syringe
FDA 510(k)
FDA Class 2
·General Hospital
COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NOVOPEN 3
FDA Adverse Event
Injury
·NOVO NORDISK A/S, MEDICAL SYSTEMS·Product code FMF·March 28, 2007
PRECISION QID
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·January 26, 2017
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·January 26, 2017
O2 OPTIX
FDA Adverse Event
Injury
·PT CIBA VISION BATAM·Product code LPM·June 19, 2014
VITROS CHEMISTRY PRODUCTS PHBR SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code DLZ·February 14, 2013
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 14, 2011
Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
FDA Enforcement
Class II
·Terminated·Vital Scientific N.V.·October 23, 2019
Medtronic INTREPID Spinal System SPACER, 32X23, 8 DEG, Size: 10MM, Part Number: REF 7961810; 12MM, REF 7961812; 14MM, REF 7961814; 16MM, REF 7961816; 18MM, REF 7961818; 20MM, REF 7961820; Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease.
FDA Recall
Terminated
·Medtronic Sofamor Danek USA Inc·Product code MAX·February 6, 2009