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
58249–58272 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 2007
ERBE ERBEJET 2 SYSTEM
K072404 · FQH
Erbe USA, Inc.
General Hospital · 65d
Cleared Oct 31, 2007
METOXIT CAM-BLANKS
K072569 · EIH
Metoxit AG
Dental · 49d
Cleared Oct 31, 2007
GAME READY CLASSIC SYSTEM, MODEL 550550
K072620 · IRP
Coolsystems, Inc.
Physical Medicine · 44d
Cleared Oct 31, 2007
COMFORT POWERED WHEELCHAIR, LY-EB 206
K072711 · ITI
Comfort Orthopedic Co., Ltd.
Physical Medicine · 36d
Cleared Oct 31, 2007
COMFORT ELECTRIC SCOOTER, LY-EW408
K072712 · INI
Comfort Orthopedic Co., Ltd.
Physical Medicine · 36d
Cleared Oct 31, 2007
GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111
K072787 · KNT
Syncro Medical Innovations, Inc.
Gastroenterology & Urology · 30d
Cleared Oct 31, 2007
1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL
K072909 · MOS
Siemens AG Medical Solutions
Radiology · 19d
Cleared Oct 31, 2007
SPEEDER 1.5T WRIST ARRAY COIL
K072935 · MOS
Quality Electrodynamics
Radiology · 14d
Cleared Oct 31, 2007
GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID
K072990 · NTE
Medtronic, Inc.
Cardiovascular · 7d
Cleared Oct 30, 2007
LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8
K070315 · KNF
Lina Medical Aps
Obstetrics & Gynecology · 271d
Cleared Oct 30, 2007
BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1
K072097 · LBI
Medical Select, Inc.
General Hospital · 91d
Cleared Oct 30, 2007
NOVOFLO CATHETER LT
K072499 · MSD
Novosci, Inc.
Gastroenterology & Urology · 55d
Cleared Oct 30, 2007
FAXITRON SPECIMEN RADIOGRAPHY SYSTEM, MODEL MX-20
K072557 · MWP
Faxitron X-Ray Corp.
Radiology · 49d
Cleared Oct 30, 2007
SYMBIA-E, MODEL 10275879
K072567 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 48d
Cleared Oct 30, 2007
MC 3003G-32R HEAD COIL
K072931 · MOS
Mr Instruments, Inc.
Radiology · 14d
Cleared Oct 29, 2007
Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX
K062542 · DZE
Z-Systems AG
Dental · 425d
Cleared Oct 29, 2007
TERRAQUANT MQ2000 V.5 WITH THE TQ-1TENS
K071445 · ILY
Escada International, Inc.
Physical Medicine · 158d
Cleared Oct 29, 2007
APACERAM BONE GRAFT SUBSTITUTE
K071912 · MQV
Pentax Corp.
Orthopedic · 110d
Cleared Oct 29, 2007
VALEO CERVICAL PLATE SYSTEM
K071990 · KWQ
Amedica Corp.
Orthopedic · 101d
Cleared Oct 29, 2007
D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL...
K072091 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 91d
Cleared Oct 29, 2007
BIOPRO MEMORY STAPLE, MODELS 18062-18073
K072298 · JDR
Biopro, Inc.
Orthopedic · 73d
Cleared Oct 29, 2007
NEUROVISION JJB SYSTEM
K072343 · GWF
Nuvasive, Inc.
Neurology · 69d
Cleared Oct 29, 2007
MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00
K072918 · ITX
Toshibamedical Systems Corporation
Radiology · 14d
Cleared Oct 26, 2007
TROJAN-ENZ BRAND
K071313 · HIS
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 169d