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

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175,820 results
39673–39696 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 26, 2013
STERITEC GREEN CARD PACK BOWIE-DICK TEST
K132372 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 119d
Cleared Nov 26, 2013
KNIT-PAK+
K132526 · MVL
Premier Dental Products Co.
Dental · 106d
Cleared Nov 26, 2013
TRIATHLON TRITANIUM METAL-BACKED PATELLA
K132624 · MBH
Stryker Orthopaedics
Orthopedic · 96d
Cleared Nov 26, 2013
AIGIS RX N (MEDIUM), AIGIS RX N (LARGE)
K132699 · FTL
Tyrx, Inc.
General & Plastic Surgery · 89d
Cleared Nov 26, 2013
SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM
K132740 · NQW
Spinefrontier, Inc.
Orthopedic · 84d
Cleared Nov 26, 2013
CYBERWAND STERILE PROBE SET
K132795 · FFK
Cybersonics, Inc.
Gastroenterology & Urology · 81d
Cleared Nov 26, 2013
BD MAX STAPHSR ASSAY, INSTRUMENT
K132822 · NQX
Geneohm Sciences Canada, Inc. (Bd...
Microbiology · 78d
Cleared Nov 26, 2013
C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM...
K133330 · JIX
Roche Diagnostics
Chemistry · 25d
Cleared Nov 25, 2013
DANA REUSABLE BI TEST PACK
K130135 · JOJ
Dana Products, Inc.
General Hospital · 311d
Cleared Nov 25, 2013
INBODY
K130777 · MNW
Biospace Corporation Limited
Gastroenterology & Urology · 249d
Cleared Nov 25, 2013
BIA / VITALITY ANALYZER
K130856 · MNW
Ipgdx, LLC
Gastroenterology & Urology · 242d
Cleared Nov 25, 2013
CAPNOMASK
K131339 · CCK
Mediplus , Ltd.
Anesthesiology · 200d
Cleared Nov 25, 2013
VAULT-C INTERVERTEBRAL BODY FUSION DEVICE
K132029 · OVE
Spinal USA
Orthopedic · 147d
Cleared Nov 25, 2013
ANAX 5.5 SPINAL SYSTEM
K132101 · MNH
U&I Corporation
Orthopedic · 140d
Cleared Nov 25, 2013
ARTHREX COMPRESSION FT SCREWS
K132217 · HWC
Arthrex, Inc.
Orthopedic · 131d
Cleared Nov 25, 2013
VALVED TEARAWAY INTRODUCER GENERATION II
K132498 · DYB
Medcomp (Medical Components, Inc.)
Cardiovascular · 108d
Cleared Nov 25, 2013
TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM
K132504 · KWP
Corelink, LLC
Orthopedic · 105d
Cleared Nov 25, 2013
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
K132509 · MQB
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 105d
Cleared Nov 25, 2013
TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA
K132544 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 104d
Cleared Nov 25, 2013
BLACK COLOURED CONDOM
K132597 · HIS
Karex Industries Sdn. Bhd.
Obstetrics & Gynecology · 98d
Cleared Nov 25, 2013
CD HORIZON SPINAL SYSTEM
K132639 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 94d
Cleared Nov 25, 2013
PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
K132884 · NKB
Zimmer Spine, Inc.
Orthopedic · 73d
Cleared Nov 25, 2013
CHARRUAPACS SYSTEM
K133357 · LLZ
Charruasoft SA
Radiology · 25d
Cleared Nov 22, 2013
BREATH SHAKE
K121587 · BYI
Cheen Houng Ent. Co. , Ltd.
Anesthesiology · 540d