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

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175,820 results
33697–33720 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 29, 2015
EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER...
K152675 · KDJ
Baxter Healthcare
Gastroenterology & Urology · 41d
Cleared Oct 28, 2015
Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95...
K141876 · MSH
Pasture Pharma Pte, Ltd.
General Hospital · 474d
Cleared Oct 28, 2015
Cavex Cream Alginate
K151535 · ELW
Cavex Holland BV
Dental · 142d
Cleared Oct 28, 2015
Rainbow Trans
K151723 · EIH
Genoss
Dental · 124d
Cleared Oct 28, 2015
Genesys Spine TiLock2 Spinal System
K152039 · NKB
Genesys Spine
Orthopedic · 98d
Cleared Oct 28, 2015
Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as...
K152095 · LEJ
Cosmedico Light, Inc.
General & Plastic Surgery · 92d
Cleared Oct 28, 2015
Tempus IC2
K152124 · MWI
Remote Diagnostics Technologies, Ltd.
Cardiovascular · 89d
Cleared Oct 28, 2015
VS3-IR system
K152204 · OWN
Visionsense, Ltd.
General & Plastic Surgery · 83d
Cleared Oct 28, 2015
JOURNEY II Uni Tibial Base and Insert
K152315 · HSX
Smith & Nephew, Inc.
Orthopedic · 72d
Cleared Oct 28, 2015
VERTEX(r) Reconstruction System
K152338 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 70d
Cleared Oct 28, 2015
RiverLon (Nylon) Suture
K152795 · GAR
Riverpoint Medical
General & Plastic Surgery · 30d
Cleared Oct 27, 2015
ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe
K143306 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 343d
Cleared Oct 27, 2015
Genesis II XLPE Resurfacing Patellar Components
K150241 · JWH
Smith & Nephew, Inc.
Orthopedic · 267d
Cleared Oct 27, 2015
Acetabular Cup Orientation System
K150780 · PLW
Materialise NV
Orthopedic · 216d
Cleared Oct 27, 2015
Guardian 1000
K151629 · GEX
Quanta System Spa
General & Plastic Surgery · 132d
Cleared Oct 27, 2015
Anchorage 2 CP System
K151769 · HRS
Stryker GmbH
Orthopedic · 119d
Cleared Oct 27, 2015
PremiPatch PTFE Pledget
K151865 · DXZ
Aesculap, Inc.
Cardiovascular · 111d
Cleared Oct 27, 2015
A7 Anesthesia System
K151954 · BSZ
Shenzhen Mindray Bio-Medical...
Anesthesiology · 104d
Cleared Oct 27, 2015
Codman Certas Plus Programmable Valve
K152152 · JXG
Medos International SARL
Neurology · 85d
Cleared Oct 27, 2015
Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC...
K152169 · JWH
Ortho Development Corporation
Orthopedic · 84d
Cleared Oct 27, 2015
Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value...
K152363 · DXQ
Philips Medical Systems
Cardiovascular · 68d
Cleared Oct 27, 2015
CD HORIZON Spinal System
K152457 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 60d
Cleared Oct 27, 2015
Express SD Biliary Monorail Premounted Stent System
K152607 · FGE
Boston Scientific
Gastroenterology & Urology · 46d
Cleared Oct 27, 2015
ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL...
K152801 · DXQ
Statcorp Medical
Cardiovascular · 29d