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
29041–29064 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 2017
Plasma Edge System
K163090 · FAS
Chirurgie Innovation
Gastroenterology & Urology · 200d
Cleared May 23, 2017
Prontosan Wound Gel
K163430 · FRO
B.Braun Medical, Inc.
General & Plastic Surgery · 167d
Cleared May 23, 2017
ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay
K163658 · CEW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 151d
Cleared May 23, 2017
Fortilink™-C with TETRAfuse™ 3D Technology
K163673 · ODP
Rti Surgical, Inc.
Orthopedic · 147d
Cleared May 23, 2017
Skylit Phototherapy System
K170489 · FTC
Skylit Medical
General & Plastic Surgery · 95d
Cleared May 22, 2017
OSSTEM Implant System - Abutment
K161689 · NHA
Osstem Implant Co., Ltd.
Dental · 336d
Cleared May 22, 2017
Hybrid3D
K163394 · KPS
Hermes Medical Solutions AB
Radiology · 168d
Cleared May 22, 2017
Powder Free Nitrile Patient Examination Gloves, Blue
K163553 · LZA
Hebei Titans Medical Supply...
General Hospital · 154d
Cleared May 22, 2017
SMV Scientific Cannulated Screws
K170021 · HWC
Smv Scientific
Orthopedic · 139d
Cleared May 22, 2017
Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories
K170121 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 129d
Cleared May 22, 2017
Smith & Nephew VISIONAIRE Adaptive Guides
K170282 · JWH
Smith & Nephew, Inc.
Orthopedic · 112d
Cleared May 22, 2017
Strep B Carrot Broth One-Step
K170586 · PQZ
Hardy Diagnostics
Microbiology · 83d
Cleared May 22, 2017
Dymaxeon Spine System
K170989 · NKB
Back 2 Basics Direct, LLC
Orthopedic · 49d
Cleared May 22, 2017
Pinpoint GT Needle Guide Kits
K171348 · ITX
C.R. Bard, Inc.
Radiology · 14d
Cleared May 21, 2017
LT-300 SD Digital Video Colposcope
K170446 · HEX
Lutech Industries, Inc.
Obstetrics & Gynecology · 96d
Cleared May 19, 2017
Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber
K160109 · NVP
Thayer Medical Corporation
Anesthesiology · 486d
Cleared May 19, 2017
MICRORUPTOR 6
K160677 · GEX
Meridian AG
General & Plastic Surgery · 435d
Cleared May 19, 2017
BEAMSCAN
K161807 · IYE
Ptw-Freiburg Physikalisch...
Radiology · 322d
Cleared May 19, 2017
Frova Intubating Introducer
K161813 · BTR
William Cook Europe Aps
Anesthesiology · 322d
Cleared May 19, 2017
DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
K162212 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 284d
Cleared May 19, 2017
OsteoMed PINNACLE Driver
K162542 · HBE
Osteomed
Neurology · 249d
Cleared May 19, 2017
Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder
K163073 · JKA
Sol-Millennium Medical, Inc.
Chemistry · 198d
Cleared May 19, 2017
AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded...
K163261 · FZP
AtriCure, Inc.
General & Plastic Surgery · 179d
Cleared May 19, 2017
SLIT LAMP SL-2000
K163564 · HJO
Nidek Co., Ltd.
Ophthalmic · 151d