14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SERVO-U Ventilator System, SERVO-n Ventilator System
FDA 510(k)
FDA Class 2
·Anesthesiology
Orthopedic Salvage System (OSS)
FDA UDI
Biomet Orthopedics, LLC·00880304674370·
Apex Connect
FDA UDI
META SYSTEMS CO., LTD.·08809455602003·Apex Connect File Holder Adapter
DIRECT CROWN NATURAL 1
FDA 510(k)
FDA Class 2
·Dental
JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180529119·MICROSCOPE DP - LIF, CUP CURETTE, STRAIGHT, 90 ...
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
ATHREX
FDA Adverse Event
ATHREX INC·Product code HRX·June 3, 2013
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151814
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code JDI·July 2, 2019
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151814
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·August 21, 2019
TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
FDA Recall
Terminated
·Theralase Inc.·Product code NHN·September 26, 2019
TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
FDA Recall
Terminated
·Theralase Inc.·Product code NHN·September 26, 2019
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 26, 2014