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
38065–38088 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 24, 2014
INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM
K132250 · JWJ
Integra LifeSciences Corporation
Orthopedic · 248d
Cleared Mar 24, 2014
PRODENSE BONE GRAFT SUBSTITUTE
K132656 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 210d
Cleared Mar 24, 2014
WITHINGS BLOOD PRESURE MONITOR
K133125 · DXN
Withings
Cardiovascular · 175d
Cleared Mar 24, 2014
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA...
K133232 · OMP
Kci USA, Inc. (Kinetic Concepts, Inc.)
General & Plastic Surgery · 154d
Cleared Mar 24, 2014
QB TEST
K133382 · LQD
Qbtech AB
Neurology · 140d
Cleared Mar 24, 2014
IOVERA
K133453 · GXH
Myoscience, Inc.
Neurology · 132d
Cleared Mar 24, 2014
T:SLIM INSULIN DELIVERY SYSTEM
K133593 · LZG
Tandem Diabetes Care, Inc.
General Hospital · 122d
Cleared Mar 24, 2014
VARIAX DISTAL RADIUS PLATING SYSTEM
K133974 · HRS
Stryker Leibinger GmbH
Orthopedic · 88d
Cleared Mar 21, 2014
XTRA
K131553 · CAC
Sorin Group Deutschland GmbH
Anesthesiology · 295d
Cleared Mar 21, 2014
LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
K131652 · LAF
Lin-Zhi International, Inc.
Toxicology · 289d
Cleared Mar 21, 2014
SAVE II, SAVE II BASIC
K131877 · BTL
Automedx, Inc.
Anesthesiology · 269d
Cleared Mar 21, 2014
APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET
K132011 · FMF
Aea Srl
General Hospital · 263d
Cleared Mar 21, 2014
AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL
K132031 · CHH
Axis-Shield Poc AS
Chemistry · 246d
Cleared Mar 21, 2014
ELIBRA SOFT-TISSUE FORCE SENSOR
K132104 · ONN
Kamm & Associates
Orthopedic · 256d
Cleared Mar 21, 2014
KERATOR
K132144 · DZE
LK Consulting Group USA, Inc.
Dental · 253d
Cleared Mar 21, 2014
NS 2500 HOLMIUM LASER SYSTEM
K132607 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 213d
Cleared Mar 21, 2014
DISCOVERY PET/CT 710
K133657 · KPS
Ge Medical Systems, LLC
Radiology · 114d
Cleared Mar 21, 2014
EYE SECRET 55 UV ASPHERIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
K133735 · LPL
Yung Sheng Optical Co., Ltd.
Ophthalmic · 102d
Cleared Mar 21, 2014
NOVA FA DR SYSTEM
K133782 · MQB
Sedecal., Sa.
Radiology · 99d
Cleared Mar 21, 2014
DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION...
K133786 · JCX
Dornoch Medical Systems, Inc.
General & Plastic Surgery · 99d
Cleared Mar 21, 2014
RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM
K133944 · NKB
K2m, Inc.
Orthopedic · 88d
Cleared Mar 21, 2014
TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEM
K140524 · IYN
Teratech Corp.
Radiology · 17d
Cleared Mar 20, 2014
IM60/IM70 PATIENT MONITOR
K131971 · MHX
Edan Instruments, Inc.
Cardiovascular · 265d
Cleared Mar 20, 2014
TRC-PEX, RADIC-SEALER
K132123 · KIF
Km Corporation
Dental · 253d