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
14257–14280 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 04, 2022
WaveForm L System, WaveForm TO System, WaveForm TA System
K213420 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 196d
Cleared May 04, 2022
Aurora-RT
K213526 · IYE
Magnettx Oncology Solutions , Ltd.
Radiology · 181d
Cleared May 04, 2022
HydroPICC 5F Dual Lumen Catheter
K213550 · LJS
Access Vascular, Inc.
General Hospital · 177d
Cleared May 04, 2022
ROSA ONE Brain application
K214065 · HAW
Medtech S.A.S
Neurology · 128d
Cleared May 04, 2022
Vista Ophthalmics Vitrectomy Probe
K220030 · MLZ
Vista Ophthalmics, LLC
Ophthalmic · 119d
Cleared May 04, 2022
Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine
K220700 · IZL
Yian Medical Technology (Haining)...
Radiology · 55d
Cleared May 04, 2022
Serranator PTA Serration Balloon Catheter
K220704 · PNO
Cagent Vascular, LLC
Cardiovascular · 55d
Cleared May 04, 2022
MyKnee R Pin Positioners
K220705 · JWH
Medacta International S.A.
Orthopedic · 55d
Cleared May 03, 2022
Orchid Safety Release Valve(TM)
K212064 · QOI
Linear Health Sciences, LLC
General Hospital · 305d
Cleared May 03, 2022
MVision AI Segmentation
K212915 · QKB
MVision AI
Radiology · 232d
Cleared May 03, 2022
exoplan
K213302 · LLZ
Exocad GmbH
Radiology · 211d
Cleared May 03, 2022
ECHOLASER X4
K213594 · GEX
Elesta S.P.A
General & Plastic Surgery · 172d
Cleared May 03, 2022
X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS)...
K220013 · JOY
Scopio Labs , Ltd.
Hematology · 119d
Cleared May 03, 2022
ECGenius System
K220306 · DQK
Cath Vision Aps
Cardiovascular · 90d
Cleared May 03, 2022
Cardiovascular Angiography System
K220311 · OWB
Allengers Medical Systems Limited
Radiology · 90d
Cleared May 03, 2022
LINK Endo-Model EVO Knee System
K220628 · KRO
Waldemar Link GmbH & Co. KG
Orthopedic · 60d
Cleared May 03, 2022
Surgical and Prosthetic Trays
K220791 · KCT
Dentsply Sirona
General Hospital · 46d
Cleared May 03, 2022
Intra.Ox 2.0 Handheld Tissue Oximeter
K221010 · MUD
Vioptix, Inc.
General & Plastic Surgery · 28d
Cleared May 02, 2022
Liver Suite
K211180 · JAK
GE Medical Systems SCS
Radiology · 377d
Cleared May 02, 2022
ALPHALOK™ Plating System
K212348 · HRS
Vilex, LLC
Orthopedic · 278d
Cleared May 02, 2022
Arthrx Fracture Plates
K213837 · HRS
Arthrex, Inc.
Orthopedic · 144d
Cleared May 02, 2022
ExactechGPS® System
K213877 · OLO
Blue Ortho
Orthopedic · 140d
Cleared May 02, 2022
TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)
K220283 · NUH
Hong Qiangxing (Shenzhen) Electronics...
Neurology · 90d
Cleared May 02, 2022
ARx Modular Spinal System
K220341 · NKB
Life Spine, Inc.
Orthopedic · 84d