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
43897–43920 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 05, 2012
CARDIOPACS
K120514 · LLZ
Lumedx
Radiology · 135d
Cleared Jul 05, 2012
DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN...
K120530 · DZE
Dentin Implants Technologies , Ltd.
Dental · 134d
Cleared Jul 05, 2012
SYNAPSE 3D CARDIAC TOOLS
K120636 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 126d
Cleared Jul 05, 2012
SIMPLANT GO
K120733 · LLZ
Materialise Dental NV
Radiology · 118d
Cleared Jul 05, 2012
AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM
K120739 · PHX
Tornier, Inc.
Orthopedic · 115d
Cleared Jul 05, 2012
BLUE POWER FREE NITRILE EXAMINATION GLOVE
K121464 · LZA
Northstar Healthcare Holdings
General Hospital · 49d
Cleared Jul 05, 2012
CD HORIZON SPINAL SYSTEM
K121680 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Jul 05, 2012
ACCULIF TL CAGE
K121683 · MAX
Coalign Innovations, Inc.
Orthopedic · 28d
Cleared Jul 03, 2012
TRINON Q & Q3 IMPLANT SYSTEM
K103577 · DZE
Trinon Titanium GmbH
Dental · 575d
Cleared Jul 03, 2012
NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP
K112634 · KPJ
Inotec Amd , Ltd.
General & Plastic Surgery · 298d
Cleared Jul 03, 2012
ORANGE COLORED CONDOMS ORANGE SCENT
K113056 · HIS
Karex Industries Sdn. Bhd.
Obstetrics & Gynecology · 263d
Cleared Jul 03, 2012
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C,...
K113262 · CHH
Alfa Wassermann Diagnostic...
Chemistry · 242d
Cleared Jul 03, 2012
SPINAL ELEMENTS CERCLAGE SYSTEM
K120177 · JDQ
Spinal Elements, Inc.
Orthopedic · 165d
Cleared Jul 03, 2012
U-RIGHT TD-3124 BLOOD PRESSURE MONITORING SYSTEM
K120634 · DXN
Taidoc Technology Corporation
Cardiovascular · 124d
Cleared Jul 03, 2012
PERICAM PSI
K120884 · DPT
Perimed AB
Cardiovascular · 102d
Cleared Jul 03, 2012
CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM
K120941 · DRG
Constant Care, LLC
Cardiovascular · 96d
Cleared Jul 03, 2012
DEPUY PULSE LUMBAR CAGE SYSTEM
K120966 · MAX
Medos International SARL
Orthopedic · 95d
Cleared Jul 03, 2012
SPINE FRONTIER INDUS ACP SYSTEM
K121060 · KWQ
Spinefrontier, Inc.
Orthopedic · 88d
Cleared Jul 03, 2012
FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R)
K121107 · MQP
Globus Medical, Inc.
Orthopedic · 82d
Cleared Jul 03, 2012
DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL
K121122 · DIF
Biochemical Diagnostic, Inc.
Chemistry · 81d
Cleared Jul 03, 2012
MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED...
K121336 · HIF
Surgiquest, Inc.
Obstetrics & Gynecology · 61d
Cleared Jul 03, 2012
UTB BLUE POWDER FREE NITRILE
K121506 · LZA
Northstar Healthcare Holdings
General Hospital · 43d
Cleared Jul 03, 2012
COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT...
K121629 · DTK
William Cook Europe Aps
Cardiovascular · 29d
Cleared Jul 03, 2012
WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)
K121669 · DWJ
Cincinnati Sub-Zero Products, Inc.
Cardiovascular · 27d