FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
76225–76248 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 2002
ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM
K013196 · KWP
Spinal Innovations, LLC
Orthopedic · 127d
Cleared Jan 30, 2002
LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS
K013617 · GCJ
Olympus Optical Co., Ltd.
General & Plastic Surgery · 86d
Cleared Jan 30, 2002
IDENT-A100 INTRAORAL VIDEO CAMERA
K013690 · EIA
Confident Technology, Inc.
Dental · 84d
Cleared Jan 30, 2002
MEDITRON II THESTERTHOSCOPE SYSTEM
K013725 · DQD
Meditron AS
Cardiovascular · 82d
Cleared Jan 30, 2002
COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM)
K013752 · BZG
Morgan Scientific, Inc.
Anesthesiology · 78d
Cleared Jan 30, 2002
SLEEPBITE
K013808 · LRK
Dental Imagineers, LLC
Dental · 76d
Cleared Jan 30, 2002
FINN CHAMBER (R)
K013820 · KXF
Epitest Ltd. OY
General Hospital · 75d
Cleared Jan 30, 2002
ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED...
K013824 · ELM
Dental Manufacturing S.P.A
Dental · 72d
Cleared Jan 30, 2002
D.SIGN 53, MODEL NA1012204
K014082 · EJS
Ivoclar Vivadent, Inc.
Dental · 50d
Cleared Jan 30, 2002
SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH
K014299 · DSB
Sorba Medical Systems, Inc.
Cardiovascular · 30d
Cleared Jan 30, 2002
RAVEN BACTERIAL SPORE STRIPS
K020026 · FRC
Raven Biological Laboratories, Inc.
General Hospital · 26d
Cleared Jan 30, 2002
3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM
K020045 · KWT
Biomet Orthopedics, Inc.
Orthopedic · 23d
Cleared Jan 30, 2002
PATRIOT PROTRUSIO CAGE
K020076 · JDI
Biomet Orthopedics, Inc.
Orthopedic · 21d
Cleared Jan 29, 2002
CORTISOL LIA
K010790 · CGR
Kmi Diagnostics, Inc.
Chemistry · 320d
Cleared Jan 29, 2002
SEEDNET, MODEL FP6T5, FP5T5, FP5T3
K011950 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 222d
Cleared Jan 29, 2002
METAVISION CLINICAL INFORMATION SYSTEM
K012349 · MWI
Imdsoft, Ltd.
Cardiovascular · 189d
Cleared Jan 29, 2002
REMSTAR AUTO CPAP SYSTEM
K012554 · BZD
Respironics, Inc.
Anesthesiology · 174d
Cleared Jan 29, 2002
CIC-C1Q EIA
K012576 · DAK
American Laboratory Products Co., Ltd.
Immunology · 173d
Cleared Jan 29, 2002
THERMAGE THERMACOOL TC SYSTEM
K013639 · GEI
Thermage, Inc.
General & Plastic Surgery · 85d
Cleared Jan 29, 2002
SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER...
K013641 · GEI
Senorx, Inc.
General & Plastic Surgery · 85d
Cleared Jan 29, 2002
PYRAMID ANTERIOR PLATE FIXATION SYSTEM
K013665 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 84d
Cleared Jan 29, 2002
RHODIA BITE REGISTRATION MATERIAL
K013859 · ELW
Rhodia, Inc.
Dental · 69d
Cleared Jan 29, 2002
BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS
K013959 · DKB
Bayer Diagnostics Corp.
Toxicology · 60d
Cleared Jan 29, 2002
JETSONIC 2000
K014245 · KOJ
Deldent , Ltd.
Dental · 34d