13 results
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17ms
·
Sources: EU EUDAMED, US FDA
CO2 INSUFFLATOR 1100
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89300131·Mand. 1. Molar band W-Fit right 13
Obtura Spartan
FDA UDI
Young Innovations, Inc.·00843471100615·Tip CPR-3D Diamond
Obtura Spartan
FDA UDI
OBTURA SPARTAN ENDODONTICS·00816168020268·Tip CPR-3D Diamond
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89300130501·Mand. 1. Molar band W-Fit right 13
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89300130101·Mand. 1. Molar band W-Fit right 13
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89300130051·Mand. 1. Molar band W-Fit right 13
X4 SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
Silk'n Titan Allways
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SCREWDRIVER BLADE, T7, AO
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS FREIBURG·Product code LXH·November 19, 2010
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 25, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code LWS·July 11, 2014
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP45; c) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP50; d) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP55; e) PEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP60
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024