11 results
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18ms
·
Sources: EU EUDAMED, US FDA
FUKUNDA SANGYO UNITS ELECTRONIC SPIRO
FDA 510(k)
FDA Class 2
·Anesthesiology
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668103012·LIPPMAN SIDEPORT NUCLEUS SPATULA
ACUEITY MEDICAL LIGHT SOURCE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MENTOR SMOOTH ROUND HIGH PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·July 17, 2023
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 27, 2014
ASR UNI FEMORAL IMPL SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 14, 2012
CELL-DYN SAPPHIRE VENT HEAD ASSEMBLY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·September 13, 2010
PROPONENT MRI SR
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LWP·April 16, 2022
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021