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
50473–50496 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 2010
TEMPUS IC PROFESSIONAL PATIENT MONITOR
K101264 · MWI
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 6d
Cleared May 10, 2010
CLEARVIEW EXACT II INFLUENZA A & B TEST
K092349 · PSZ
Inverness Medical, Inc.
Microbiology · 279d
Cleared May 10, 2010
REDSENSE-HOME USE
K092955 · ODX
Redsense Medical AB
Gastroenterology & Urology · 227d
Cleared May 10, 2010
ACTIPROTECT UF N95 RESPIRATOR
K093161 · ONT
Glaxosmithkline Consumer Healthcare
General Hospital · 216d
Cleared May 10, 2010
INTCO TAB ELECTRODE
K093327 · DRX
Shanghai Intco Electrode...
Cardiovascular · 196d
Cleared May 10, 2010
OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE
K093813 · KRD
Imbiotechnologies
Cardiovascular · 150d
Cleared May 10, 2010
EPIDRUM
K093863 · FMF
Exmoor Plastics , Ltd.
General Hospital · 144d
Cleared May 10, 2010
HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE),...
K100006 · GAT
Riverpoint Medical
General & Plastic Surgery · 126d
Cleared May 10, 2010
CENTRAL VISION ANALYZER MODEL 1000
K100095 · HOX
Vimetrics,Llc.
Ophthalmic · 117d
Cleared May 10, 2010
SALVIN DENTAL SPECIALTIES FIXATION SCREW
K100182 · DZL
Salvin Dental Specialties, Inc.
Dental · 109d
Cleared May 10, 2010
VLOC9ABSORBABLE WOUND CLOSURE DEVICE
K100257 · GAM
Surgical Devices, A Division of Tyco...
General & Plastic Surgery · 102d
Cleared May 10, 2010
MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L...
K100274 · DWF
Medtronic, Inc.
Cardiovascular · 101d
Cleared May 10, 2010
ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF...
K100289 · KHS
Siemens Healthcare Diagnostics
Chemistry · 97d
Cleared May 10, 2010
BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM
K101078 · DRG
Bl Healthcare, Inc.
Cardiovascular · 21d
Cleared May 07, 2010
IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6,...
K091336 · LGZ
Enthermics Medical Systems, Inc.
General Hospital · 366d
Cleared May 07, 2010
FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE...
K091812 · JEY
Frontier Devices, Inc.
Dental · 323d
Cleared May 07, 2010
SPORT-ELEC BODY CONTROL SYSTEM, MODEL 4M
K092476 · NGX
Sport-Elec
Physical Medicine · 268d
Cleared May 07, 2010
BLOOD PRESSURE MONITOR/ MODELS
K093739 · DXN
Ningbo Diaier Electronic Co., Ltd.
Cardiovascular · 154d
Cleared May 07, 2010
ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS
K093747 · OTN
C.R. Bard, Inc.
Gastroenterology & Urology · 154d
Cleared May 07, 2010
VITALOGIK 6000/6500
K093766 · DSI
Mennen Medical , Ltd.
Cardiovascular · 151d
Cleared May 07, 2010
SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM
K094002 · NKB
Spartek Medical, Inc.
Orthopedic · 130d
Cleared May 07, 2010
HYALO GYN
K094039 · NUC
Fidia Farmaceutici S.P.A.
Obstetrics & Gynecology · 128d
Cleared May 07, 2010
MEDCOM RT-VIEWER SYSTEM
K100056 · MUJ
Medcom GmbH
Radiology · 119d
Cleared May 07, 2010
SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827
K100619 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 64d