12 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Overture Orthopaedics Patellofemoral System
FDA 510(k)
FDA Class 2
·Orthopedic
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573021451·INTRG WHISP MBT CUS 0T +3A 018 LR
Rx Knee Femoral Cone Augment Reamer Size Large Stacked
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215147846·
Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation
FDA 510(k)
FDA Class 2
·Orthopedic
PERIFLUX 6000
FDA 510(k)
FDA Class 2
·Anesthesiology
ARCHITECT C16000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES (IRVING IA/CC)·Product code JJE·August 3, 2020
GE OEC 9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·November 13, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 1, 2011
RECAP SHELL COCR PC Ø54/48MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·July 17, 2013
Blue OR Towels, X-Ray Detectable, Sterile, 2 Towels per/pk; 48pk/Cs and 4 Towels per/pk; (20pk/Cs). Intended for packing and absorption externally or within patient wounds in various procedures or surgical cases.
FDA Enforcement
Class II
·Ongoing·Medical Action Industries Inc·May 24, 2017
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014