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
23161–23184 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 30, 2019
XmaruView V1 (Xmaru Chiroview, Xmaru Podview)
K190866 · LLZ
Rayence Co., Ltd.
Radiology · 27d
Cleared Apr 30, 2019
TOTIM Patient Cushion Immobilization System
K190894 · IYE
Essebi Medical Srl
Radiology · 25d
Cleared Apr 29, 2019
Compex HD
K182017 · QGO
Addent, Inc.
Dental · 276d
Cleared Apr 29, 2019
Element Pediatric Wheelchair
K182840 · IOR
Leggero, LLC
Physical Medicine · 202d
Cleared CT Apr 29, 2019
Magnetic Surgical System
K190006 · PNL
Levita Magnetics International Corp
Gastroenterology & Urology · 117d
Cleared Apr 29, 2019
HardyCHROM CRE
K190553 · JSO
Hardy Diagnostics
Microbiology · 55d
Cleared Apr 29, 2019
YelloPort Elite Port Access System
K190592 · GCJ
Surgical Innovations Limited
General & Plastic Surgery · 53d
Cleared Apr 29, 2019
Aspiron(TM) Aspiration Catheter
K190619 · QEZ
Meril Life Sciences Private Limited
Cardiovascular · 49d
Cleared Apr 29, 2019
VALO Grand Corded
K190627 · EBZ
Ultradent Products, Inc.
Dental · 48d
Cleared Apr 29, 2019
SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System
K190655 · OVE
SeaSpine Orthopedics Corporation
Orthopedic · 46d
Cleared Apr 29, 2019
MyDay
K190965 · LPL
CooperVision, Inc.
Ophthalmic · 17d
Cleared Apr 27, 2019
InterSpace Knee Extra-Large Size, InterSpace Knee ATS
K181732 · JWH
Tecres S.P.A.
Orthopedic · 299d
Cleared Apr 26, 2019
Portable Electro-Stimulation Therapy Device
K182108 · NUH
Guangzhou Longest Science &...
Neurology · 266d
Cleared Apr 26, 2019
JO Actively Trying Personal Lubricant
K182585 · PEB
United Consortium
Obstetrics & Gynecology · 218d
Cleared Apr 26, 2019
Philips IntelliVue XDS Software
K182637 · MSX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 214d
Cleared Apr 26, 2019
Cardinal HealthTM Poly-Coated Open-Back Protective Gown
K182830 · QPC
Cardinal Health200, LLC
General Hospital · 203d
Cleared Apr 26, 2019
CyclaPlex Correction System
K183094 · HTN
Cycla Orthopedics, Ltd.
Orthopedic · 170d
Cleared Apr 26, 2019
AltiVate Reverse Humeral Stem, 48mm
K190290 · KWS
Encore Medical, L.P.
Orthopedic · 74d
Cleared Apr 26, 2019
Penumbra System 3D Revascularization Device
K190464 · NRY
Penumbra, Inc.
Neurology · 59d
Cleared Apr 26, 2019
VITROS XT Chemistry Products TBIL-ALKP Slides
K190807 · CIG
Ortho-Clinical Diagnostics, Inc.
Chemistry · 28d
Cleared Apr 25, 2019
Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes
K181787 · PIF
Cedic S.R.L.
Gastroenterology & Urology · 294d
Cleared Apr 25, 2019
exCellerator Cervical Collection Device
K182049 · HHT
Excell Company, LLC
Pathology · 268d
Cleared Apr 25, 2019
Multi-Sideport Catheter Infusion Set
K182071 · KRA
Cook Incorporated
Cardiovascular · 267d
Cleared Apr 25, 2019
Smile Makers Personal Lubricant
K182100 · NUC
Lfbeauty (Thailand) Limited
Obstetrics & Gynecology · 265d