15 results · 18ms · Sources: EU EUDAMED, US FDA

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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