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
33121–33144 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 11, 2016
PURE Ceramic Implants
K151328 · DZE
Straumann USA
Dental · 238d
Cleared Jan 11, 2016
K-Y Marilyn Pleasure Gel
K151884 · NUC
Reckitt Benckiser, LLC
Obstetrics & Gynecology · 186d
Cleared Jan 11, 2016
Fortress Introducer Sheath SYstem
K153197 · DYB
Contract Medical International, GmbH
Cardiovascular · 68d
Cleared Jan 08, 2016
MyGlucoHealth Wireless System
K143169 · NBW
Entra Health Systems
Chemistry · 430d
Cleared Jan 08, 2016
Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver...
K150969 · ERL
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 270d
Cleared Jan 08, 2016
Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction...
K151018 · MQH
Cook Incorporated
Obstetrics & Gynecology · 267d
Cleared Jan 08, 2016
BioBridge Collagen Matrix
K151083 · OWY
Fibralign Corporation
Orthopedic · 261d
Cleared Jan 08, 2016
ONLINE TDM Vancomycin Gen.3
K152245 · LEH
Roche Diagnostics Operations (Rdo)
Chemistry · 151d
Cleared Jan 08, 2016
Sapphire
K152356 · BZD
Respironics, Inc.
Anesthesiology · 141d
Cleared Jan 08, 2016
VINTAGE LD
K152392 · EIH
Shofu Dental Corporation
Dental · 137d
Cleared Jan 08, 2016
LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM
K152876 · DQY
Tni Manufacturing, Inc.
Cardiovascular · 100d
Cleared Jan 08, 2016
MRI Dynamic Analysis Plus
K153039 · LNH
Esaote, S.P.A.
Radiology · 81d
Cleared Jan 08, 2016
Direct HDL Cholesterol (HDL)
K153435 · LBS
Randox Laboratories, Ltd.
Chemistry · 42d
Cleared Jan 07, 2016
Tellos ISQ Buddy
K143445 · EKX
Tellos Medical AB
Dental · 401d
Cleared Jan 07, 2016
Well Lead Ureteral Access Sheath
K151084 · FED
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 260d
Cleared Jan 07, 2016
Sterile High-pressure Angiographic Syringes for Single-use
K151960 · DXT
Shenzhen Baoan Medical Supplies Co.,...
Cardiovascular · 175d
Cleared Jan 07, 2016
TIVA¿
K152924 · JKA
Velano Vascular
Chemistry · 94d
Cleared Jan 07, 2016
Edwards Balloon Catheter
K153069 · OMZ
Edwards Lifesciences
Cardiovascular · 77d
Cleared Jan 07, 2016
Full Automatic (NIBP) Blood Pressure Monitor
K153214 · DXN
Health & Life Co., Ltd.
Cardiovascular · 63d
Cleared Jan 07, 2016
ConforMIS iTotal Posterior Stabilized Knee Replacement System
K153217 · JWH
Conformis, Inc.
Orthopedic · 63d
Cleared Jan 07, 2016
VuePoint OCT System
K153336 · NKG
Nu Vasive, Incorporated
Orthopedic · 49d
Cleared Jan 07, 2016
Volpara Imaging Software
K153427 · LLZ
Matakina Technology, Ltd.
Radiology · 43d
Cleared Jan 07, 2016
Treace Medical Concepts (TMC) Plating System
K153531 · HRS
Treace Medical Concepts, Inc.
Orthopedic · 29d
Cleared Jan 07, 2016
Coldplay CryoBalloon® Ablation System
K153541 · GEH
C2 Therapeutics, Inc.
General & Plastic Surgery · 28d