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
8713–8736 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 2024
MD Mattress Suture Placement Device
K222783 · GCJ
Lsi Solutions, Inc.
General & Plastic Surgery · 484d
Cleared Jan 11, 2024
ProxiDiagnost N90 / Precision CRF (706110, 706400)
K233945 · JAA
Philips Medical Systems Dmc GmbH
Radiology · 28d
Cleared Jan 11, 2024
PRIMA Humeral System
K233712 · MBF
Lima Corporate S.P.A.
Orthopedic · 52d
Cleared Jan 11, 2024
IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06...
K233664 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 57d
Cleared Jan 11, 2024
Clevaligner Software (V1.0.0)
K233616 · PNN
Clevaligner, Ltd.
Dental · 59d
Cleared Jan 11, 2024
Neurological Therapy Devices - Accessories: Electrotherapy device Electrode...
K232995 · GXY
Shenzhen Roundwhale Technology Co. ,...
Neurology · 111d
Cleared Jan 11, 2024
U-Lite PRO
K232285 · IYN
Sonoscanner Sarl
Radiology · 164d
Cleared Jan 11, 2024
SurgiCount+ System
K232250 · PBZ
Stryker Instruments
General & Plastic Surgery · 167d
Cleared Jan 11, 2024
CoralView® Single-use Digital Flexible Ureteroscope (U10)
K231774 · FGB
MacroLux Medical Technology Co., Ltd.
Gastroenterology & Urology · 209d
Cleared Jan 11, 2024
Disposable Hemoclip (AF series)
K231633 · PKL
Alton (Shanghai) Medical Instruments...
Gastroenterology & Urology · 220d
Cleared Jan 11, 2024
Copper Foam Dressing (Prescription and OTC)
K231088 · FRO
Roosin Medical Co., Ltd.
General & Plastic Surgery · 269d
Cleared Jan 11, 2024
ToxiSeal Vial Adapter with External Balloon
K222929 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 472d
Cleared Jan 10, 2024
CarboClear® X Pedicle Screw System
K233944 · NKB
CarboFix Orthopedics , Ltd.
Orthopedic · 27d
Cleared Jan 10, 2024
Zeta Cranial Navigation System (ZNS131-US)
K233903 · HAW
Zeta Surgical, Inc.
Neurology · 30d
Cleared Jan 10, 2024
Centurion™ Vision System (Active Sentry™) (8065753057)
K233902 · HQC
Alcon Laboratories, Inc.
Ophthalmic · 30d
Cleared Jan 10, 2024
Axon Therapy
K233364 · QPL
Neuralace Medical, Inc.
Physical Medicine · 100d
Cleared Jan 10, 2024
Numen Coil Embolization System
K232955 · HCG
MicroPort NeuroTech (Shanghai) Co., Ltd.
Neurology · 111d
Cleared Jan 10, 2024
LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC)...
K232604 · LDJ
Hangzhou Laihe Biotech Co., Ltd.
Toxicology · 135d
Cleared Jan 09, 2024
1788 4K Camera System with Advanced Imaging Modality
K233327 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 102d
Cleared Jan 09, 2024
Dental Cone-beam Computed Tomography
K232710 · OAS
Yian Medical Technology (Haining)...
Radiology · 126d
Cleared Jan 09, 2024
LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test...
K232597 · DJG
Hangzhou Laihe Biotech Co., Ltd.
Toxicology · 134d
Cleared Jan 09, 2024
GORE® PROPATEN® Vascular Graft
K232312 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 160d
Cleared Jan 08, 2024
Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db...
K233615 · GEI
Baisheng Medical Co., Ltd.
General & Plastic Surgery · 56d
Cleared Jan 08, 2024
InkSpace Imaging Small Body Array
K233444 · MOS
Inkspace Imaging, Inc.
Radiology · 81d