28 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AnapnoGuard 100 Respiratory Guard System
FDA 510(k)
FDA Class 2
·Anesthesiology
HHM
FDA UDI
Oticon A/S·05707131285836·H150V2, RITE 312 WL DBL HHM
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690111665·Modular Stem 15mm x 75mm
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100080·TEMPORAL SPECULUM OPEN WIRE
Tibial Trial Tray Size 2
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215074074·
MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
SYSLOC MINI V3
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·December 14, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·August 8, 2023
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 29, 2023
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 27, 2023
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·October 7, 2022
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·October 15, 2019
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 5, 2023
FRESENIUS 2008H
FDA Adverse Event
Death
·FRESENIUS USA·Product code FII·July 25, 2007
FRESENIUS 2008H
FDA Adverse Event
Other
·FRESENIUS USA·Product code FII·August 8, 2007
UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JGS·February 2, 2010
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
FDA Enforcement
Class II
·Ongoing·CORIN MEDICAL, LTD.·July 9, 2025
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·October 7, 2014
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 6, 2013