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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
69985–70008 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 2004
EPICOR MEDICAL ABLATION SYSTEM
K022894 · NTB
Epicor Medical, Inc.
General & Plastic Surgery · 541d
Cleared Feb 26, 2004
ENVOY PATIENT MONITOR
K030722 · MHX
Mennen Medical, Inc.
Cardiovascular · 356d
Cleared Feb 26, 2004
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB
K031097 · JXG
Sophysa SA
Neurology · 325d
Cleared Feb 26, 2004
COOK FIVE LUMEN CENTRAL VENOUS CATHETER
K032274 · FOZ
Cook, Inc.
General Hospital · 218d
Cleared Feb 26, 2004
3M COLOR MEDICAL FLAT PANEL DISPLAY, CCL316
K032555 · LLZ
Totoku Electric Co., Ltd.
Radiology · 191d
Cleared Feb 26, 2004
ORTHODONTIC COMPOSITE BRACKET SYSTEM
K032625 · DYW
Ultradent Products, Inc.
Dental · 184d
Cleared Feb 26, 2004
NEOSOOTHE POLYMER COATED POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION...
K033086 · LZA
Pt. Medisafe Technologies
General Hospital · 150d
Cleared Feb 26, 2004
PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY
K033479 · LLH
Remel, Inc.
Microbiology · 115d
Cleared Feb 26, 2004
OSSTELL MENTOR RFA
K033689 · EKX
Integration Diagnostics, Ltd.
Dental · 94d
Cleared Feb 26, 2004
DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER
K040184 · DTM
Cobe Cardiovascular, Inc.
Cardiovascular · 31d
Cleared Feb 26, 2004
MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM
K040201 · JXG
Integra Neurosciences Implants S.A.
Neurology · 28d
Cleared Feb 26, 2004
CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT
K040252 · MCW
Rex Medical
Cardiovascular · 22d
Cleared Feb 25, 2004
ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM
K033053 · JCT
Alveolus, Inc.
General & Plastic Surgery · 149d
Cleared Feb 25, 2004
COLORADO MICRODISSECTION NEEDLE
K033232 · GEI
Stryker Corp.
General & Plastic Surgery · 142d
Cleared Feb 25, 2004
LIGHT AGE Q-CLEAR LASER, MODEL 701-1101
K033259 · GEX
Light Age, Inc.
General & Plastic Surgery · 139d
Cleared Feb 25, 2004
VERTEBRON PSS PEDICLE SCREW SYSTEM
K033352 · MNI
Vertebron, Inc.
Orthopedic · 128d
Cleared Feb 25, 2004
CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474,...
K033395 · GXO
Codman & Shurtleff, Inc.
Neurology · 125d
Cleared Feb 25, 2004
TRANSET FRACTURE FIXATION SYSTEM
K033717 · HTY
Bonutti Research, Inc.
Orthopedic · 91d
Cleared Feb 25, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE...
K033940 · LTT
Dade Behring, Inc.
Microbiology · 68d
Cleared Feb 25, 2004
SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975
K033981 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 64d
Cleared Feb 25, 2004
GOLDWAY UT4000A VITAL SIGNS MONITOR
K033988 · MWI
Goldway Us, Inc.
Cardiovascular · 64d
Cleared Feb 25, 2004
ELECSYS C-PEPTIDE CALCHECK
K040157 · JJX
Roche Diagnostics Corp.
Chemistry · 33d
Cleared Feb 25, 2004
BISX
K040183 · OLW
Aspect Medical Systems, Inc.
Neurology · 29d
Cleared Feb 25, 2004
MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP...
K040214 · DQA
Masimo Corp.
Anesthesiology · 26d