14 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TROJAN NIRVANA COLLECTION LUBRICATED CONDOMS
FDA Adverse Event
Injury
·CHURCH & DWIGHT CO., INC.·Product code HIS·June 24, 2020
TROJAN PLEASURE PACK LUBRICATED CONDOMS
FDA Adverse Event
Injury
·CHURCH & DWIGHT CO., INC.·Product code HIS·October 29, 2014
TROJAN (TM-TBD) CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Stryker Universal Select Sterilization Tray System
FDA UDI
PARAGON MEDICAL, INC.·00857387006213·1.2 Orbital Plates/Mesh Module
NA
FDA UDI
STERILMED, INC.·10888551007535·SAW BLADE SAGITTAL K9 K2000 SERIES
NA
FDA UDI
STERILMED, INC.·10888551007528·SAW BLADE SAGITTAL K9 K2000 SERIES
COLOR-MONOGEN
FDA 510(k)
FDA Class 2
·Immunology
EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FOUNDATION SHOULDER
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWS·November 11, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 14, 2014
TEGADERM CHG DRESSING
FDA Adverse Event
Other
·3M HEALTH CARE·Product code FRO·December 18, 2012
TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°
FDA Adverse Event
Death
·STRYKER TRAUMA KIEL·Product code HSB·September 29, 2015
Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023