11 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACU-EVAC
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Obtura Spartan
FDA UDI
Young Innovations, Inc.·00843471100547·Tip BUC-3
Obtura Spartan
FDA UDI
OBTURA SPARTAN ENDODONTICS·00816168020312·Tip BUC-3
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515236578·Swiss Osteotome, 13cm, 5 1/8", 12mm edge, cvd
Grasping forceps
FDA UDI
SOPRO-COMEG GmbH·04059082022857·
PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
Insulin Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·January 25, 2013
INTERSTIM
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·November 18, 2010
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 11, 2014
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