9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
NEURO SPONGE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HomeSafe (Wireless) Home Communicator
FDA UDI
Lifeline Systems Company·00884838071667·7000C Home Communicator
MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER
FDA 510(k)
FDA Class 2
·Radiology
IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 30, 2014
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LFR·November 20, 2012
COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 21, 2010
BD PLATE CAMPYLOBACTER SB 100MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON DE MEXICO·Product code JSJ·June 2, 2022
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