Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
36625–36648 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 2014
CUTANEOUS ELECTRODES
K142099 · GXY
Bio Protech, Inc.
Neurology · 108d
Cleared Nov 17, 2014
Speed, Speed Shift, Speed Titan, Speed Arc
K142292 · JDR
Biomedical Enterprises, Inc.
Orthopedic · 91d
Cleared Nov 14, 2014
HEPARIN LOCK / FLUSH SYRINGES
K133446 · NZW
Excelsior Medical Corporation
General Hospital · 367d
Cleared Nov 14, 2014
TECOTHERM NEO (T NEO)
K140078 · DWJ
Inspiration Healthcare, Ltd.
Cardiovascular · 305d
Cleared Nov 14, 2014
RESPIRONICS REUSABLE HEATED TUBING
K140424 · BZE
Respironics, Inc.
Anesthesiology · 268d
Cleared Nov 14, 2014
MICRO GUIDE CATHETER ELITE
K140438 · PDU
Cordis Corp., A Johnson & Johnson Co.
Cardiovascular · 266d
Cleared Nov 14, 2014
GARMENT ELECTRODES
K141076 · GXY
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 203d
Cleared Nov 14, 2014
OTC COMBO TENS/EMS SYSTEM
K141299 · NUH
Well-Life Healthcare Limited
Neurology · 179d
Cleared CT Nov 14, 2014
CL DETECT RAPID TEST
K141341 · PIT
InBios International, Inc.
Microbiology · 177d
Cleared Nov 14, 2014
WEARABLE THERAPY GARMENTS
K141342 · GXY
Axiobionics, LLC
Neurology · 177d
Cleared Nov 14, 2014
JOURNEY II XR KNEE SYSTEM
K141471 · JWH
Smith & Nephew, Inc.
Orthopedic · 164d
Cleared Nov 14, 2014
CLEANER ROTATIONAL THROMBECTOMY SYSTEM
K141617 · QEW
Rex Medical, L.P.
Cardiovascular · 150d
Cleared Nov 14, 2014
NUVASIVE NVM5 SYSTEM
K141968 · PDQ
Nuvasive, Inc.
Neurology · 116d
Cleared Nov 14, 2014
BULK FILL FLOWABLE COMPOSITE
K141994 · EBF
Novocol, Inc.
Dental · 115d
Cleared Nov 14, 2014
V20 SYSTEM
K142093 · GEX
Viora , Ltd.
General & Plastic Surgery · 105d
Cleared Nov 14, 2014
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR...
K142161 · JWH
Conformis, Inc.
Orthopedic · 100d
Cleared Nov 14, 2014
MINOP Disposable Introducer 26F
K142315 · GWG
Aesculap, Inc.
Neurology · 87d
Cleared Nov 14, 2014
TITAN Modular Total Shoulder System
K142413 · KWS
Ascension Orthopedics
Orthopedic · 78d
Cleared Nov 14, 2014
Restoration Anatomic Shell
K142462 · LPH
Stryker Orthopaedics
Orthopedic · 73d
Cleared Nov 14, 2014
Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior...
K142565 · DQY
Stryker Neurovascular
Cardiovascular · 63d
Cleared Nov 14, 2014
Panorama Patient Monitoring Network
K142601 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 64d
Cleared Nov 14, 2014
WEGO-PGCL Absorbable Surgical Monofilament Suture
K142810 · GAM
Foosin Medical Supplies Inc., Ltd.
General & Plastic Surgery · 46d
Cleared Nov 14, 2014
Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh),...
K142908 · FTL
Sofradim Production
General & Plastic Surgery · 39d
Cleared Nov 13, 2014
ABL90 FLEX
K132691 · MQM
Radiometer Medical Aps
Chemistry · 442d