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
32809–32832 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 03, 2015
CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
K152582 · DSK
Volcano Corporation
Cardiovascular · 84d
Cleared Dec 03, 2015
Portable X-ray System (Model: MINIX-V / MINIX-S)
K152859 · EHD
Digimed Co., Ltd. (Digimed...
Radiology · 64d
Cleared Dec 03, 2015
SYDNEY IVF EMBRYO BIOPSY MEDIUM
K152904 · MQL
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 63d
Cleared Dec 03, 2015
Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir
K153213 · DTZ
Terumo Cardiovascular Systems...
Cardiovascular · 28d
Cleared Dec 02, 2015
Reaxon Plus
K143711 · JXI
Medovent GmbH
Neurology · 338d
Cleared Dec 02, 2015
EnFocus 2300, EnFocus 4400
K150722 · HLI
Bioptigen, Inc.
Ophthalmic · 257d
Cleared Dec 02, 2015
Universal Spike
K150787 · LHI
B.Braun Medical, Inc.
General Hospital · 252d
Cleared Dec 02, 2015
Zero-P Natural Plate System
K152239 · KWQ
Synthes (Usa), LLC
Orthopedic · 114d
Cleared Dec 02, 2015
Attachable Cath Lab Hemostasis Valve
K152528 · DTL
Galt Medical Corp.
Cardiovascular · 90d
Cleared Dec 02, 2015
PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01,...
K152566 · MBI
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared Dec 02, 2015
XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory
K152632 · NKB
Stryker Corporation
Orthopedic · 78d
Cleared Dec 02, 2015
Lantern Delivery Microcatheter
K152840 · DQY
Penumbra, Inc.
Cardiovascular · 64d
Cleared Dec 02, 2015
Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18...
K153140 · DTZ
Terumo Cardiovascular Systems Corp.
Cardiovascular · 33d
Cleared Dec 02, 2015
Capiox Advance Hardshell Reservoir
K153143 · DTN
Terumo Cardiovascular Systems...
Cardiovascular · 33d
Cleared Dec 01, 2015
RX-FIX Mini Rail External Fixator
K150640 · KTT
Wrightmedicaltechnologyinc
Orthopedic · 265d
Cleared Dec 01, 2015
Biodenta Customized Abutment - Titanium
K151295 · NHA
Biodenta Swiss AG
Dental · 200d
Cleared Dec 01, 2015
Gmate Origin Blood Glucose Monitoring System
K151658 · NBW
Philosys, Inc.
Chemistry · 165d
Cleared Dec 01, 2015
Video Colposcope
K151878 · HEX
Edan Instruments, Inc.
Obstetrics & Gynecology · 145d
Cleared Dec 01, 2015
3M Attest Rapid Readout Biological Indicator 1295
K152060 · FRC
3M Company
General Hospital · 130d
Cleared Dec 01, 2015
NuVent EM Sinus Dilation System
K152121 · LRC
Medtronic Xomed, Inc.
Ear, Nose, Throat · 124d
Cleared Dec 01, 2015
Glidesheath
K152173 · DYB
Terumo Medical Corporation
Cardiovascular · 119d
Cleared Dec 01, 2015
PCT System
K152211 · NKG
Centinel Spine, Inc.
Orthopedic · 116d
Cleared Dec 01, 2015
Adler MicroMed Laser Surgery Fibers
K152417 · GEX
Adler Micromed, Inc.
General & Plastic Surgery · 97d
Cleared Dec 01, 2015
NuVasive Foundation-LL System
K152943 · OVD
Nu Vasive, Incorporated
Orthopedic · 57d