FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
5881–5904 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 2024
ProGear® Surgical Mask with Oxafence®, Model AV82030
K231741 · OUK
Prestige Ameritech
General Hospital · 449d
Cleared Sep 05, 2024
ICX-Implant System
K231566 · DZE
Medentis Medical GmbH
Dental · 463d
Cleared Sep 04, 2024
SignalNED System (Model RE)
K242306 · OMC
Forest Devices, Inc.
Neurology · 30d
Cleared Sep 04, 2024
BE Plus PRO, Neurotravel LIGHT
K242305 · GWL
Eb Neuro S.P.A.
Neurology · 30d
Cleared Sep 04, 2024
NextDent Jet Denture Base
K241071 · EBI
Vertex-Dental B.V.
Dental · 138d
Cleared Sep 04, 2024
DreamClear
K240646 · GWL
Somnomed Technologies Inc., Doing...
Neurology · 181d
Cleared Sep 04, 2024
Modular Medical MODD1 Insulin Delivery System
K240158 · LZG
Modular Medical, Inc.
Chemistry · 229d
Cleared Sep 04, 2024
FUJIFILM Endoscope Model EG-840N
K240142 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 230d
Cleared Sep 04, 2024
Velacur
K233977 · IYO
Sonic Incytes
Radiology · 261d
Cleared Sep 04, 2024
Mini Screws
K231502 · OAT
Proimtech Saglik Urunleri Anonim Sirketi
Dental · 469d
Cleared Sep 04, 2024
Tamper Evident Cap
K231095 · FMF
International Medical Industries, Inc.
General Hospital · 505d
Cleared Sep 04, 2024
Qraycam PRO
K221275 · NBL
AIOBIO Co., Ltd.
Dental · 856d
Cleared Sep 03, 2024
Indigo® Aspiration System – Aspiration Catheter 6X
K242319 · QEW
Penumbra, Inc.
Cardiovascular · 29d
Cleared Sep 03, 2024
Litho 60
K242251 · GEX
Quanta System Spa
General & Plastic Surgery · 34d
Cleared Sep 03, 2024
Eminent Spine Scoliosis Deformity Pedicle Screw System
K242069 · NKB
Eminent Spine
Orthopedic · 50d
Cleared Sep 03, 2024
ShapeIT (SI014135)
K241611 · DQY
Imds Operations B.V.
Cardiovascular · 90d
Cleared Sep 03, 2024
SOMATOM On.site
K241295 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 118d
Cleared Sep 03, 2024
EVOS Patella Plates
K240487 · HRS
Smith & Nephew
Orthopedic · 196d
Cleared Sep 03, 2024
K5
K233805 · EIA
Osstem Implant Co., Ltd. Chair Business
Dental · 279d
Cleared Aug 31, 2024
Arthrex VAL and VAL KreuLock™ Compression Screw System
K241592 · HWC
Arthrex, Inc.
Orthopedic · 89d
Cleared Aug 30, 2024
MI View&GO
K242300 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Aug 30, 2024
syngo.via MI Workflows
K242275 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Aug 30, 2024
Conformity Stem Extension Line
K242249 · LZO
United Orthopedic Corporation
Orthopedic · 30d
Cleared Aug 30, 2024
Talee, Talee PostOp
K241957 · MVA
Invent Medical USA, LLC
Neurology · 58d