16 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Safey Peak Flow Meter
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777648·LUMBAMED BASIC DORSAL STAYS M SILVER II
OsteoMed
FDA UDI
OSTEOMED LLC·00845694057189·T Handle, ICON
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365118401·
STEROTACTIC LOCALIZATION DEVICE (SLD)
FDA 510(k)
FDA Class 2
·Radiology
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Widex
FDA UDI
Widex A/S·05706069735697·Widex BEYOND B-F2 (Titan grey S-330 ) Telecoil,...
SNAP-RING FOR 52MM OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWB·December 4, 2007
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 15, 2015
ECCENTRICAL GLENOSPHERE DIA. 40 MM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A·Product code MBF·December 19, 2022
AMS SPHINCTER 800 URINARY PROSTHESIS
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code EZY·August 8, 2011
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 22, 2014
LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 Ø11X280MM X 125°
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code HSB·July 2, 2013
Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number 6290-00-704. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 10, 2014
Olympus Sterile Optical Laser Fiber, single use and reusable
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·June 16, 2021
Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016