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
22297–22320 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 2019
Stat Profile Prime ES Comp Plus Analyzer System
K191626 · JFP
Nova Biomedical Corporation
Chemistry · 59d
Cleared Aug 16, 2019
APTUS Foot System
K191636 · JDR
Medartis AG
Orthopedic · 58d
Cleared Aug 16, 2019
SKR 4000
K191645 · MQB
Konica Minolta, Inc.
Radiology · 58d
Cleared Aug 16, 2019
Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro...
K191899 · CFR
Roche Diagnostics
Chemistry · 31d
Cleared Aug 16, 2019
SAFECARE® THC Urine Strip Test
K191924 · NFW
Safecare Biotech (Hangzhou) Co., Ltd.
Toxicology · 29d
Cleared Aug 16, 2019
COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT...
K191933 · HQC
Johnson & Johnson Surgical Vision, Inc.
Ophthalmic · 28d
Cleared Aug 16, 2019
Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS...
K192018 · ODP
Titan Spine, Inc.
Orthopedic · 18d
Cleared Aug 15, 2019
Suprasorb A + Ag “R”
K183208 · FRO
Speciality Fibres and Materials, Ltd.
General & Plastic Surgery · 269d
Cleared Aug 15, 2019
OneDraw A1C Test System
K183230 · LCP
Drawbridge Health, Inc.
Chemistry · 268d
Cleared CT Aug 15, 2019
Biovitals Analytics Engine
K183282 · PLB
Biofourmis Singapore Pte., Ltd.
Cardiovascular · 262d
Cleared Aug 15, 2019
Viola
K190264 · NEW
Meditime Co., Ltd.
General & Plastic Surgery · 188d
Cleared Aug 15, 2019
HCT Empty EVA Container Pack
K190328 · KPE
Health Care Technologies
General Hospital · 183d
Cleared Aug 15, 2019
Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
K190610 · NLQ
Sterilmed, Inc.
General & Plastic Surgery · 157d
Cleared Aug 15, 2019
HeartFlow FFRct Analysis
K190925 · PJA
HeartFlow, Inc.
Cardiovascular · 128d
Cleared Aug 15, 2019
Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal...
K190991 · MBH
Howmedica Osteonics Corp. (Aka...
Orthopedic · 122d
Cleared CT Aug 15, 2019
TULSA-PRO System
K191200 · PLP
Profound Medical, Inc.
Gastroenterology & Urology · 101d
Cleared Aug 15, 2019
ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical...
K191621 · ODP
Choice Spine, LLC
Orthopedic · 58d
Cleared Aug 15, 2019
Stryker CMF MEDPOR Priority Customized Implant Kit
K191916 · FWP
Stryker Leibinger GmbH & Co KG
General & Plastic Surgery · 29d
Cleared Aug 15, 2019
ACUSON P200 Diagnostic Ultrasound System
K191922 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Aug 14, 2019
SleepImage System
K182618 · MNR
Mycardio, LLC Dba Sleepimage.
Anesthesiology · 324d
Cleared Aug 14, 2019
Servator C SALF Solution
K190063 · MSB
S.A.L.F. Spa
Gastroenterology & Urology · 211d
Cleared Aug 14, 2019
BOSS Toe Fixation System
K190261 · KWD
Arthrosurface, Inc.
Orthopedic · 187d
Cleared Aug 14, 2019
SignalMark Breast Marker
K190689 · NEU
View Point Medical, Inc.
General & Plastic Surgery · 149d
Cleared Aug 14, 2019
IS-III active System_S-narrow Type
K190849 · DZE
Neobiotech Co., Ltd.
Dental · 135d