9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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e-fix E35/E36
FDA 510(k)
FDA Class 2
·Physical Medicine
Ceramco® II Silver™
FDA UDI
Dentsply International Inc.·D0011612410·
McKesson
FDA UDI
MCKESSON MEDICAL-SURGICAL INC.·00612479280939·Silicone Wound Contact Layer Dressing SILICONE ...
BIOLUCENT APPLICATOR, MODEL RTA-XX
FDA 510(k)
FDA Class 2
·Radiology
REPLENS LONG-LASTING VAGINAL MOISTURIZER (PRE-FILLED APPLICATOR)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
INSYNC SENTRY
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NIK·October 10, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
FREESTYLE FLASH
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 10, 2008
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
FDA Enforcement
Class II
·Terminated·Cardiovascular Systems Inc·May 31, 2017