11 results
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19ms
·
Sources: EU EUDAMED, US FDA
ESTRIOL RIA KIT FOR USE WITH GAMMAFLO
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Oph.Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668117972·Short Caps. Fcps, Fmd Sharp Tip, Flat
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209125616·
AFFIRM CO2 AND AFFIRM CO2 HP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD
FDA 510(k)
FDA Class 2
·General Hospital
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 8, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 23, 2012
SOFTCLIX® PLUS LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·August 16, 2010
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
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025