9 results
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26ms
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Sources: EU EUDAMED, US FDA
ICON STREP B IMMUNOENZYMETRIC ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
Medi-Inn
FDA UDI
TIDI PRODUCTS, LLC·00618125143689·Medi-Inn X-ray Cassette/Detector Covers Clear P...
Accu-Beam
FDA UDI
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL·B177911417150·Re-usable fiberoptic handpiece for lasers.
Ben...
THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ULTRASOUND SCANNER, TYPE 2102
FDA 510(k)
FDA Class 2
·Radiology
UMBILI-CATH
FDA Adverse Event
Malfunction
·UTAH MEDICAL PRODUCTS, INC.·Product code FOS·November 17, 2010
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·January 11, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 3, 2014
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS40
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024