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
51625–51648 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 07, 2009
MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411
K092793 · GXY
Bio-Medical Research, Ltd.
Neurology · 87d
Cleared Dec 07, 2009
STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTS
K092951 · EBZ
Mectron S.P.A.
Dental · 74d
Cleared Dec 07, 2009
HYLATOPIC PLUS EMOLLIENT FOAM
K093051 · FRO
Collegium Pharmaceutical Incorporated
General & Plastic Surgery · 68d
Cleared Dec 07, 2009
WITTMANN PATCH
K093166 · FTL
Aperta, LLC
General & Plastic Surgery · 62d
Cleared Dec 07, 2009
QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR
K093522 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 24d
Cleared CT Dec 04, 2009
DIDGET BLOOD GLUCOSE METER, MODEL 6181
K090628 · NBW
Bayer Healthcare, LLC
Chemistry · 270d
Cleared Dec 04, 2009
EMSI GARMENT ELECTRODES
K090889 · GXY
Emsi
Neurology · 248d
Cleared Dec 04, 2009
INTEGRA MOZAIK AND OS MOLDABLE MORSELS
K091302 · MQV
Integra LifeSciences Corporation
Orthopedic · 214d
Cleared Dec 04, 2009
SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05
K091352 · OBJ
Biosense Webster, Inc.
Cardiovascular · 211d
Cleared Dec 04, 2009
RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18
K091507 · MSS
Rayner Intraocular Lenses , Ltd.
Ophthalmic · 197d
Cleared Dec 04, 2009
GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15
K091582 · DQX
Medtronic Vascular
Cardiovascular · 185d
Cleared Dec 04, 2009
DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES
K091672 · GEI
Shuyou Electric Medical Science Co.,...
General & Plastic Surgery · 178d
Cleared Dec 04, 2009
OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK
K091838 · HIH
Obp Medical
Obstetrics & Gynecology · 165d
Cleared Dec 04, 2009
TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500
K092482 · MUU
Shippert Medical Technologies Corp.
General & Plastic Surgery · 113d
Cleared Dec 04, 2009
UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES
K092514 · DXN
Hangzhou Hua'An Medical & Health...
Cardiovascular · 109d
Cleared Dec 04, 2009
COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY
K092603 · CFR
Roche Diagnostics
Chemistry · 101d
Cleared Dec 04, 2009
MD300C318 FINGERTIP PULSE OXIMETER
K092620 · DQA
Beijing Choice Electronic Technololgy...
Anesthesiology · 100d
Cleared Dec 04, 2009
AMIGO ESCORT 7.5, MODEL 760001 PHS
K092936 · ITI
Amigo Mobility Intl., Inc.
Physical Medicine · 71d
Cleared Dec 04, 2009
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K092956 · LYZ
Shandong Aobo Medical Co, Ltd.
General Hospital · 70d
Cleared Dec 04, 2009
ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS
K093165 · GEI
Arthrocare Corp.
General & Plastic Surgery · 59d
Cleared Dec 04, 2009
VIAMO SSA-640A VERSION 1.2
K093171 · IYN
Toshiba America Medical Systems, In.C
Radiology · 57d
Cleared Dec 04, 2009
3M COMPLY BOWIE- DICK TYPE LEAD FREE TEST PACK
K093199 · JOJ
3M Company
General Hospital · 56d
Cleared Dec 04, 2009
D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT
K093233 · OMG
Diagnostic Hybrids, Inc.
Microbiology · 51d
Cleared Dec 04, 2009
CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES
K093455 · DQK
Biosense Webster, Inc.
Cardiovascular · 29d