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
66097–66120 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 27, 2005
EKOS ULTRASOUND INFUSION SYSTEM
K041826 · NUI
Ekos Corp.
Neurology · 294d
Cleared Apr 27, 2005
DATAPRO CLINICAL CHELISTRY ANALYZER
K042767 · CFR
Thermo Electron Corporation
Chemistry · 204d
Cleared Apr 27, 2005
ACCU-CHEK AVIVA SYSTEM
K043474 · LFR
Roche Diagnostics Corp.
Chemistry · 132d
Cleared Apr 27, 2005
COLACTIVE COLLAGEN WOUND DRESSING
K050177 · KGN
Covalontechnologies, Inc.
General & Plastic Surgery · 91d
Cleared Apr 27, 2005
EPIGUARD
K050188 · JXL
Episafe Medical Devices, Ltd.
Neurology · 90d
Cleared Apr 27, 2005
INFPUMP INFILTRATION PUMP
K050324 · FRN
Carolina Medical, Inc.
General Hospital · 77d
Cleared Apr 27, 2005
MICROMEDICS SPHENOID SINUS STENT
K050340 · KAM
Micromedics, Inc.
General & Plastic Surgery · 75d
Cleared Apr 27, 2005
HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES
K050508 · KKX
Haywood Vocational Opportunities
General Hospital · 58d
Cleared Apr 27, 2005
LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS...
K050537 · JJY
Bio-Rad
Chemistry · 56d
Cleared Apr 27, 2005
NEXUS DETACHABLE COIL SYSTEM
K050543 · HCG
Micro Therapeutics, Inc.
Neurology · 56d
Cleared Apr 27, 2005
SYNTHES (USA) 3.5MM CONICAL SCREWS
K050683 · HWC
Synthes (Usa)
Orthopedic · 41d
Cleared Apr 27, 2005
AESCULAP ORTHOPILOT 2 THA V 2.0
K050752 · HAW
Aesculap, Inc.
Neurology · 35d
Cleared Apr 27, 2005
REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE
K050837 · FLL
Ge Healthcare
General Hospital · 26d
Cleared Apr 27, 2005
CENTRION 500 C-ARM SYSTEM
K050866 · JAA
Osteosys Co.,Ltd
Radiology · 22d
Cleared Apr 27, 2005
DIGITAL RADIOGRAPHY MODEL CXDI-40EG
K050987 · MQB
Canon, Inc.
Radiology · 8d
Cleared Apr 27, 2005
SPINEMED S200B/S200C
K051013 · ITH
Cert Health Sciences, LLC
Physical Medicine · 6d
Cleared Apr 26, 2005
MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1
K043380 · DPS
Monebo Technologies, Inc.
Cardiovascular · 139d
Cleared Apr 26, 2005
MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS
K050157 · LPL
Bausch & Lomb, Inc.
Ophthalmic · 91d
Cleared Apr 26, 2005
AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES
K050194 · GXZ
Axon Systems, Inc.
Neurology · 89d
Cleared Apr 26, 2005
APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR
K050256 · GAD
Apple Medical Corp.
General & Plastic Surgery · 82d
Cleared Apr 26, 2005
SBI HAND FIXATION SYSTEM (TM)
K050462 · HRS
Small Bone Innovations, LLC
Orthopedic · 62d
Cleared Apr 26, 2005
QUANTIA LA(A)
K050487 · DFC
Biokit, S.A.
Chemistry · 60d
Cleared Apr 26, 2005
ECLIPSE LATEX POWDER FREE STERILE SURGEON'S GLOVE
K050533 · KGO
Regent Medical Americas, LLC
General Hospital · 55d
Cleared Apr 26, 2005
HEMOSIL D-DIMER HS
K050544 · DAP
Instrumentation Laboratory CO
Hematology · 55d