11 results
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18ms
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Sources: EU EUDAMED, US FDA
THE BELLCO FISTULA NEEDLES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Oph.Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668118108·Brown Glaucoma Tube Forceps
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209129096·
SURE-SNAP
FDA UDI
Gc Orthodontics America Inc.·E53580163200001·SURE-SNAP 1. MOLAR UPR RGT SZ 32
OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009
FDA 510(k)
FDA Class 1
·Clinical Chemistry
METAFLEXCOIL
FDA 510(k)
FDA Class 2
·Radiology
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 9, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 23, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·September 27, 2007
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021