15 results
·
19ms
·
Sources: EU EUDAMED, US FDA
SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122963·K-WIRE - SINGLE TROCAR 0.9mm DIA x 150mm
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471156036·K-WIRE - SINGLE TROCAR 0.9mm DIA x 230mm
IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POISE DATAENGINE
FDA 510(k)
FDA Class 2
·Cardiovascular
PROXIMATE ILS CIRCULAR STAPLERS
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KOG·June 13, 2006
K-WIRE Ø1.4 W/DOUB TIP L150 SST
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code LRN·February 4, 2013
CL NON-DEHP SOL SET 10 DPM .22FILTER 102" Y@6 W/2PC LL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·December 29, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 17, 2014
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·August 20, 2019
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·March 17, 2020
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·May 22, 2020
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·June 4, 2020
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·September 13, 2017
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025