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
25393–25416 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 2018
AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters
K173762 · DQO
AngioDynamics, Inc.
Cardiovascular · 219d
Cleared Jul 18, 2018
NeoLSD MSMS kit
K173829 · PQW
Wallac Oy, A Subsidiary of Perkinelmer
Chemistry · 212d
Cleared Jul 18, 2018
ACCUSYTE 3D Fiducial Marker
K180027 · IYE
Radiation Products, LLC
Radiology · 196d
Cleared Jul 18, 2018
ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES
K180784 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 114d
Cleared Jul 18, 2018
KARL STORZ New Generation Trocars
K180977 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 96d
Cleared Jul 18, 2018
Tritanium PL Cage
K181014 · MAX
Stryker Spine
Orthopedic · 92d
Cleared Jul 18, 2018
Braun BFH175 Infrared Forehead Thermometer
K181015 · FLL
Kaz USA, Inc., A Helen of Troy Company
General Hospital · 92d
Cleared Jul 18, 2018
Ultra Facial Toning System
K181062 · NFO
Micro Current Technology, Inc.
Neurology · 86d
Cleared Jul 18, 2018
SeaSpine Regatta Lateral System
K181079 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 85d
Cleared Jul 18, 2018
ATLANTIS Conus Structure
K181189 · NHA
Dentsply Sirona
Dental · 76d
Cleared Jul 18, 2018
ARIETTA 65
K181376 · IYN
Hitachi Healthcare Americas Corporation
Radiology · 55d
Cleared Jul 17, 2018
Cook-Swartz Doppler Flow Probe
K171272 · ITX
Cook Incorporated
Radiology · 442d
Cleared Jul 17, 2018
Ureteral Dilator Sets, Ureteral Dilators
K173654 · EZN
Cook Incorporated
Gastroenterology & Urology · 231d
Cleared Jul 17, 2018
Stat Profile Prime Plus Analyzer System
K173797 · CHL
Nova Biomedical Corporation
Chemistry · 215d
Cleared Jul 17, 2018
Straumann Variobase for Bridge/Bar Cylindrical
K173968 · NHA
Institut Straumann AG
Dental · 200d
Cleared Jul 17, 2018
Cadwell Apollo System
K180269 · GWQ
Cadwell Industries, Inc.
Neurology · 167d
Cleared Jul 17, 2018
Field Orthopaedics Micro Screw System
K180348 · HWC
Field Orthopaedics Pty, Ltd.
Orthopedic · 159d
Cleared Jul 17, 2018
Sonicision Reusable Sterilization Tray
K180915 · KCT
Covidien
General Hospital · 99d
Cleared Jul 17, 2018
Rubicon Lumbar Interbody Fusion System
K181030 · MAX
Rubicon Spine, LLC
Orthopedic · 90d
Cleared Jul 17, 2018
Apex Femoral Nailing System
K181375 · HSB
Orthoxel
Orthopedic · 54d
Cleared Jul 16, 2018
MC3 Jugular Dual Lumen Catheter
K180151 · PZS
Mc3 Incorporated
Cardiovascular · 178d
Cleared Jul 16, 2018
EIDON FA
K180526 · MYC
Centervue S.P.A.
Ophthalmic · 139d
Cleared Jul 16, 2018
Philips IntelliVue GuardianSoftware
K180534 · DXJ
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 138d
Cleared Jul 16, 2018
Atellica IM BRAHMS Procalcitonin (PCT)
K181002 · PMT
Siemens Healthcare Diagnostics, Inc.
Microbiology · 91d