10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
HISTIMUNE ENZYME-ANA TEST
FDA 510(k)
FDA Class 2
·Immunology
Tranquil-C™
FDA UDI
NEXUS SPINE, L.L.C.·B6788223460·Cervical Rasp 12x18x14
CLEANTEXX MINT FLAVOUR BLUE COLOUR POWDER-FREE BARRIER PRO COPOLYMER EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
ALUMINUM SCOOP DISK
FDA 510(k)
FDA Class 1
·Physical Medicine
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·March 2, 2023
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 20, 2014
PLASMABLADE TISSUE DISSECTION DEVICE
FDA Adverse Event
Malfunction
·MEDTRONIC ADVANCED ENERGY LLC·Product code GEI·October 25, 2012
ENDOPATH** XCEL* BLADELESS TROCAR WITH STABILITY SLEEVE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·September 1, 2010
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025