13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)
FDA 510(k)
FDA Class 2
·Anesthesiology
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950013159·VELCRO STRAP 2X12" W/BUCKLE L/F
Isomedix Operations Inc.
FDA registration
Isomedix Operations Inc.·137 products·🇺🇸 United States
AVANOS
FDA UDI
Avanos Medical, Inc.·00350770987132·MIC-KEY* Continuous Feed Extension Set
RANDOX DIGITOXIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
RUBBERCARE POLYMER-CHLORINATED POWDER-FREE GUARDIAN POLYMER-CHLORINATED POWDER-FREE
FDA 510(k)
FDA Class 1
·General Hospital
GRASPING RETRACTOR INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·November 12, 2013
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·FLEXTRONICS EMS CANADA·Product code FNL·March 6, 2013
XACT CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIM·March 28, 2011
STARCLOSE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·April 18, 2008
BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 2014
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018