FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
32521–32544 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 2016
CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)
K152509 · NHA
Altatec GmbH
Dental · 132d
Cleared Jan 12, 2016
Bio2 CLM BG Bioactive Scaffold
K152589 · MQV
Bio2 Technologies, Inc.
Orthopedic · 124d
Cleared Jan 12, 2016
INFX-8000V, V6.20
K152696 · OWB
Toshibamedical Systems Corporation
Radiology · 113d
Cleared Jan 12, 2016
Biograph Horizon PET/CT
K152880 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 104d
Cleared Jan 12, 2016
MUSE Cardiology Information System
K152993 · DQK
Ge Medical Systems Information...
Cardiovascular · 91d
Cleared Jan 12, 2016
Sofia Influenza A+B FIA
K153012 · PSZ
Quidel Corporation
Microbiology · 90d
Cleared Jan 12, 2016
Cios Connect
K153147 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 74d
Cleared Jan 12, 2016
3MP Color LCD Monitor, RadiForce RX350
K153354 · PGY
Eizo Corporation
Radiology · 53d
Cleared Jan 11, 2016
Sysmex Automated Blood Coagulation Analyzer CS-5100
K150678 · JPA
Siemens Healthcare Diagnostic...
Hematology · 301d
Cleared Jan 11, 2016
Universa Soft Ureteral Stents and Stent Sets
K151051 · FAD
Cook Incorporated
Gastroenterology & Urology · 266d
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