14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AblatePal Radiofrequency Ablation System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HEALIX ADVANCE PERMACORD
FDA UDI
Medos International Sàrl·10886705024759·HEALIX ADVANCE PEEK 3 SUTURE ANCHOR w/ PERMACOR...
Adler Instrument Company
FDA UDI
Adler, Inc.·00810123201631·TC MAYO-HEGAR NH 6-1/4 MATTE
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·May 24, 2005
IMAGE3 SE DISPOSABLE FULL FACE MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
AXERA 2 ACCESS SYSTEM MODEL AXE200
FDA 510(k)
FDA Class 2
·Cardiovascular
NATURALTYE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 31, 2014
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·August 16, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 12, 2013
4.5 HEALIXADVPEEK3SUTANC PCORD
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·May 25, 2018
4.5 HEALIXADVPEEK3SUTANC PCORD
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·January 2, 2019
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025