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
35329–35352 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 2015
TheyFit Male Condom
K150072 · HIS
Theyfit
Obstetrics & Gynecology · 90d
Cleared Apr 14, 2015
Sidecar External Working Channel
K150083 · FED
C2 Therapeutics
Gastroenterology & Urology · 89d
Cleared Apr 14, 2015
JUSHA-M52C Medical Display
K150746 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 22d
Cleared Apr 13, 2015
Monopolar Laparascopic Accessories
K142208 · GEI
Unimicro Medical Systems (Shenzhen)...
General & Plastic Surgery · 245d
Cleared Apr 13, 2015
PINPOINT GT SAFETY INTRODUCER NEEDLE
K142445 · DYB
C.R. Bard, Inc.
Cardiovascular · 223d
Cleared Apr 13, 2015
Lubricating Jelly
K142473 · KMJ
Sion Biotext Medical , Ltd.
General Hospital · 222d
Cleared Apr 13, 2015
mint Lesion
K142647 · LLZ
Mint Medical GmbH
Radiology · 208d
Cleared Apr 13, 2015
Pulse Oximeter
K142687 · DQA
Shanghai Berry Electronic Tech Co., Ltd.
Anesthesiology · 203d
Cleared Apr 13, 2015
MDT Navigable Brain Biopsy Cannula
K143241 · HAW
Izi Medical Products, LLC
Neurology · 152d
Cleared Apr 13, 2015
Neoss Ti Reinforced Membrane
K143327 · NPK
Neoss, Ltd.
Dental · 144d
Cleared Apr 13, 2015
SoundCure Serenade Tinnitus Treatment System
K150065 · KLW
Soundcure, Inc.
Ear, Nose, Throat · 90d
Cleared Apr 13, 2015
IMMULITE IGF Control Module, IMMULITE Gastrin Control Module
K150132 · JJX
Siemens Healthcare Diagnostics
Chemistry · 82d
Cleared Apr 13, 2015
DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS
K150516 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 42d
Cleared Apr 13, 2015
FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm...
K150705 · GCJ
Minimally Invasive Devices, Inc.
General & Plastic Surgery · 26d
Cleared Apr 13, 2015
Diamondback 360 Peripheral Orbital Atherectomy System
K150732 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 24d
Cleared Apr 10, 2015
BREAST-MED TISSUE MARKER
K133697 · NEU
Breast-Med, Inc.
General & Plastic Surgery · 493d
Cleared Apr 10, 2015
HEALTH KIOSK
K140360 · DXN
Engagementhealth, LLC
Cardiovascular · 422d
Cleared Apr 10, 2015
Disposable sterile needle retractable safety syringe
K141349 · MEG
Guangdong Haiou Medical Apparatus...
General Hospital · 323d
Cleared Apr 10, 2015
AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS...
K141932 · OYE
Beckman Coulter, Inc.
Immunology · 268d
Cleared Apr 10, 2015
COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
K142094 · JSM
Copan Italia Spa
Microbiology · 252d
Cleared Apr 10, 2015
AUTION CHECK PLUS
K142262 · JJW
Quantimetrix Corp.
Chemistry · 239d
Cleared Apr 10, 2015
GPS Spacers
K142456 · ODP
G Surgical, LLC
Orthopedic · 220d
Cleared Apr 10, 2015
ZM Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K142911 · LYZ
Huailai ZM Plastic Products Co., Ltd.
General Hospital · 186d
Cleared Apr 10, 2015
FORE-SIGHT Elite Absolute Tissue Oximeter
K143675 · MUD
Cas Medical Systems, Inc.
Cardiovascular · 107d