Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
34153–34176 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 01, 2015
HyaloGYN Vaginal Hydrating Gel
K150883 · NUC
Fidia Farmaceutici S.P.A.
Obstetrics & Gynecology · 152d
Cleared Sep 01, 2015
CIRRUS HD-OCT
K150977 · OBO
Carl Zeiss Meditec, Inc.
Ophthalmic · 141d
Cleared Sep 01, 2015
TRAUS SUS10
K151171 · DZI
Saeshin Precision Co., Ltd.
Dental · 123d
Cleared Sep 01, 2015
NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm...
K151473 · GEX
Focus Medical, LLC
General & Plastic Surgery · 92d
Cleared Sep 01, 2015
Dynarex Eye Cups
K151575 · LXQ
Dynarex Corporation
Ophthalmic · 82d
Cleared Sep 01, 2015
BOX DICOM Viewer
K151957 · LLZ
Box, Inc.
Radiology · 47d
Cleared Aug 31, 2015
Dental Implant OKTAGON Bone Level
K143539 · DZE
Hager& Meisinger GmbH
Dental · 259d
Cleared Aug 31, 2015
Normal Saline Flush
K150143 · NGT
Nurse Assist, Inc.
General Hospital · 221d
Cleared Aug 31, 2015
Biogel PI Micro Indicator Underglove
K150146 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 221d
Cleared Aug 31, 2015
Vitality Spinal Fixation System
K150896 · NKB
Zimmer Spine, Inc.
Orthopedic · 151d
Cleared Aug 31, 2015
EarlySense Central Display Station (CDS)
K151006 · MSX
Earlysense, Ltd.
Cardiovascular · 138d
Cleared Aug 31, 2015
Integra Total Ankle Replacement System
K151459 · HSN
Ascension Orthopedics
Orthopedic · 91d
Cleared Aug 31, 2015
Sniper Spine System
K152174 · MNI
Spine Wave, Inc.
Orthopedic · 27d
Cleared Aug 28, 2015
UTAH CVX-RIPE
K143424 · PFJ
Utah Medical Products, Inc.
Obstetrics & Gynecology · 270d
Cleared Aug 28, 2015
Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN...
K143433 · IKT
Natus Manufacturing Limited
Neurology · 270d
Cleared Aug 28, 2015
NuVasive Sterilization Trays
K143579 · KCT
Nu Vasive, Incorporated
General Hospital · 253d
Cleared Aug 28, 2015
ANAM Test System: Military Battery
K150154 · PKQ
Vista Lifesciences, Inc.
Neurology · 217d
Cleared Aug 28, 2015
PDO Absorbable Punctum Plug
K150288 · LZU
Riverpoint Medical
Ophthalmic · 204d
Cleared Aug 28, 2015
Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator
K150412 · DAE
The Binding Site Group , Ltd.
Immunology · 191d
Cleared Aug 28, 2015
Sensititre 18-24 hours MIC or BP Susceptibility System with...
K150556 · JWY
Thermo Fisher Scientific
Microbiology · 177d
Cleared Aug 28, 2015
VIA 21 Microcatheter
K150894 · DQY
Sequent Medical, Inc.
Cardiovascular · 148d
Cleared Aug 28, 2015
Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
K150962 · OQO
Focus Diagnostics
Microbiology · 140d
Cleared Aug 28, 2015
DMRC Bulk Fill
K151088 · EBF
Danville Materials, LLC
Dental · 127d
Cleared Aug 28, 2015
Fingertip Pulse Oximeter
K151206 · DQA
Beijing Choice Electronic Technololgy...
Anesthesiology · 114d