11 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PNEUMOTHORAX KIT, MODIFICATION
FDA 510(k)
FDA Class 2
·Orthopedic
Alleset
FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918166834·Alleset Gown_no reinforcement_L/Xlong_43g SMS_N...
Alleset
FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918121260·Alleset Gown_no reinforcement_L/Xlong_w/ 2 Hand...
F1 DIODE LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 9, 2013
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEM·November 21, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 1, 2014
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
FDA Enforcement
Class I
·Ongoing·Zyno Medical LLC·June 18, 2025
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024