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
23809–23832 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 2019
Velofix Interbody Fusion System
K190067 · ODP
U&I Corporation
Orthopedic · 20d
Cleared Feb 01, 2019
Pedimax II - Pedicular Screw Spinal System
K180626 · NKB
Gm Dos Reis Industria E Comerico Ltda.
Orthopedic · 329d
Cleared Feb 01, 2019
iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)
K181070 · NBW
Andon Health Co, Ltd.
Chemistry · 284d
Cleared Feb 01, 2019
easyLCTM Linear Cutter Staplers and Loading Units fot Single Use
K181657 · GDW
Ezisurg Medical Co., Ltd.
General & Plastic Surgery · 224d
Cleared Feb 01, 2019
HemoCue Hb 801 System
K181751 · GKR
Hemocue AB
Hematology · 214d
Cleared Feb 01, 2019
Family of Venus RF Systems - Heal
K182094 · PBX
Venus Concept USA, Inc.
General & Plastic Surgery · 182d
Cleared Feb 01, 2019
Invia Abdominal Dressing Kit
K182191 · OMP
Medela AG
General & Plastic Surgery · 172d
Cleared Feb 01, 2019
Glo-Tip Spray Catheter
K182319 · OCX
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 158d
Cleared Feb 01, 2019
HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High
K182744 · GGM
Eurotrol B.V.
Hematology · 126d
Cleared Feb 01, 2019
Endoscope Sterilization Tray
K183139 · KCT
Intuitive Surgical, Inc.
General Hospital · 80d
Cleared Feb 01, 2019
AI Rad Companion (Engine)
K183272 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 70d
Cleared Feb 01, 2019
DR 800 with Tomosynthesis
K183275 · IZF
Agfa N.V.
Radiology · 70d
Cleared Feb 01, 2019
Supria True64 Whole-Body X-Ray CT System
K183291 · JAK
Hitachi Healthcare Americas
Radiology · 67d
Cleared Feb 01, 2019
Vbeam Prima Laser System
K183452 · GEX
Candela Corp.
General & Plastic Surgery · 50d
Cleared Feb 01, 2019
SECULOK™ ACP System
K190053 · KWQ
U&I Corporation
Orthopedic · 21d
Cleared Jan 31, 2019
STRONG Dental Handpieces
K181129 · EGS
Saeshin Precision Co., Ltd.
Dental · 276d
Cleared Jan 31, 2019
Panoura X-ERA PF/NF/MF
K182198 · MUH
The Yoshida Dental Mfg. Co., Ltd.
Radiology · 170d
Cleared Jan 31, 2019
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900
K182827 · MED
STERIS Corporation
General Hospital · 118d
Cleared Jan 31, 2019
Endosee System
K183020 · HIH
CooperSurgical, Inc.
Obstetrics & Gynecology · 91d
Cleared Jan 30, 2019
Patient Cables and Leadwires , Disposable ECG Leadwires
K182327 · DSA
Orantech, Inc.
Cardiovascular · 156d
Cleared Jan 30, 2019
Boston Keratoprosthesis, Type I Lucia
K182986 · HQM
Massachusetts Eye and Ear Infirmary...
Ophthalmic · 93d
Cleared Jan 30, 2019
MOTO Partial Knee System
K183029 · HSX
Medacta International S.A.
Orthopedic · 90d
Cleared Jan 30, 2019
Zimmer Segmental System Proximal Femoral Component
K183136 · LZO
Zimmer, Inc.
Orthopedic · 78d
Cleared Jan 30, 2019
Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid
K183696 · PHX
Tornier, Inc.
Orthopedic · 30d