24 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75
FDA 510(k)
FDA Class 2
·Cardiovascular
BiPAP A30
FDA UDI
Respironics, Inc.·00606959039391·BiPAP SOH Ventilator
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK111151·DD tempMED are pre-colored dental milling blank...
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08806390849623·
CLEARFIX RIGID STERNAL FIXATION Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089436750·
Summa Orthopaedics System Surgical Instrument
FDA UDI
Jeil Medical Corporation·08806390875363·
ELIPAR FREELIGHT
FDA 510(k)
FDA Class 2
·Dental
CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L
FDA 510(k)
FDA Class 2
·Anesthesiology
SURESIGNS VS2+ NBP/SPO2/WIRELESS
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code MHX·August 26, 2021
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 21, 2023
CONTOUR TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·February 1, 2010
CONTOUR TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·May 7, 2010
ONE TOUCH BASIC
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·February 25, 2003
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 13, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 8, 2025
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 14, 2013
INTERSTIM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code EZW·September 23, 2014
KNIFE
FDA Adverse Event
Other
·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·May 26, 2011
M2A TPR HI CARBON 41/32MM LNR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWY·September 21, 2018
32MM M2A HI CARBON HD -6MM NK
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWY·September 21, 2018