FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
28057–28080 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 2017
Non-Sterile, Single use, Powder-free examination glove tested for use with...
K171378 · LZA
Semperit Investments Asia Pte , Ltd.
General Hospital · 127d
Cleared Sep 14, 2017
Range/Denali/Mesa Spinal System
K171832 · NKB
K2m, Inc.
Orthopedic · 86d
Cleared Sep 14, 2017
Bard Mission Disposable Core Biopsy Instrument
K171953 · KNW
Bard Peripheral Vascular, Inc.
Gastroenterology & Urology · 77d
Cleared Sep 14, 2017
Veress Needle
K172120 · FHO
Wickimed (Huizhou) Medical Equipment...
Gastroenterology & Urology · 63d
Cleared Sep 14, 2017
Clarius Ultrasound System
K172385 · IYN
Clarius Mobile Health Corp.
Radiology · 37d
Cleared Sep 14, 2017
Amsel Occluder Device
K172479 · FZP
Amsel Medical
General & Plastic Surgery · 29d
Cleared Sep 14, 2017
IntelliCart System
K172481 · JCX
Dornoch Medical Systems
General & Plastic Surgery · 29d
Cleared Sep 14, 2017
3D Echo
K172513 · LLZ
Jointvue, LLC
Radiology · 24d
Cleared Sep 13, 2017
AnemoCheck
K163215 · KHG
Sanguina, LLC
Hematology · 301d
Cleared Sep 13, 2017
HORIZON Therapy System
K171051 · OBP
Magstim Company, Ltd.
Neurology · 156d
Cleared Sep 13, 2017
NeuViz Prime Multi-slice CT Scanner System
K171201 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 142d
Cleared Sep 13, 2017
Pollogen Legend+ System
K171359 · GEI
Pollogen, Ltd.
General & Plastic Surgery · 127d
Cleared Sep 13, 2017
Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview...
K171664 · GKA
Bio-Rad Laboratories, Inc.
Hematology · 100d
Cleared Sep 13, 2017
FibroScan 430 Mini+
K172142 · IYO
Echosens
Radiology · 58d
Cleared Sep 12, 2017
tremoFlo C-100 Airwave Oscillometry System
K170185 · PNV
Thorasys Thoracic Medical Systems, Inc.
Anesthesiology · 232d
Cleared Sep 12, 2017
PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System
K170409 · GEX
Topcon Medical Laser Systems, Inc....
General & Plastic Surgery · 214d
Cleared Sep 12, 2017
da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site...
K170875 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 172d
Cleared Sep 12, 2017
Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel
K171144 · FMI
Medbio, LLC
General Hospital · 146d
Cleared Sep 12, 2017
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound...
K171233 · IYN
Shenzhen Mindray Bio-Meidcal...
Radiology · 138d
Cleared Sep 12, 2017
CAPI 3 Hb A1c
K171537 · PDJ
Sebia
Chemistry · 110d
Cleared Sep 12, 2017
NEO Pedicle Screw System™
K171582 · NKB
Neo Medical SA
Orthopedic · 104d
Cleared Sep 12, 2017
cobas Cdiff Nucleic acid test for use on the cobas Liat System
K171770 · OZN
Roche Molecular Systems, Inc.
Microbiology · 90d
Cleared Sep 11, 2017
Tri Auto ZX2
K170275 · EKX
J. Morita USA, Inc.
Dental · 224d
Cleared Sep 11, 2017
Sterile NS System
K170368 · GWO
Jeil Medical Corporation
Neurology · 217d