9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
PLATE INCUBATOR
FDA 510(k)
FDA Class 1
·Microbiology
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209118816·KIT, IFAK - CUSTOM
AxSOS 3Ti
FDA 510(k)
FDA Class 2
·Orthopedic
RELI-ON ONE STEP, ORTHODONTIC ADHESIVE
FDA 510(k)
FDA Class 2
·Dental
PUMP MMT-722NAS PRDGM INS V2.2 SK EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·October 1, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 23, 2014
CIRCUIT NEONATE 4FT HTD W/ 30/CS
FDA Adverse Event
Malfunction
·CAREFUSION·Product code BZE·November 30, 2012
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP40
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024