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
76633–76656 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 11, 2002
HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB AND RIGHT LIMB
K012956 · JOW
Hygia Health Services, Inc.
Cardiovascular · 219d
Cleared Apr 11, 2002
POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER
K013160 · MSD
Spire Biomedical, Inc.
Gastroenterology & Urology · 202d
Cleared Apr 11, 2002
MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE
K020099 · GEX
Biolitec, Inc.
General & Plastic Surgery · 90d
Cleared Apr 11, 2002
INTRAORAL CAMERA ME-15
K020206 · EIA
Dent Corp. Research & Development
Dental · 79d
Cleared Apr 11, 2002
AVON PATELLAR COMPONENT
K020841 · KRR
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared Apr 11, 2002
MODIFICATION TO FOX PTA CATHETER
K020854 · LIT
Jomed AG
Cardiovascular · 27d
Cleared Apr 10, 2002
IMMEDIATE STABILIZING DEVICE (ISD)
K011524 · DZE
"O" Co., Inc.
Dental · 328d
Cleared Apr 10, 2002
MAHURKAR TRIPLE LUMEN CATHETER, 12 FR
K020089 · NIE
The Kendall Company
Gastroenterology & Urology · 90d
Cleared Apr 10, 2002
VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER
K020106 · DTR
Gish Biomedical, Inc.
Cardiovascular · 89d
Cleared Apr 10, 2002
UD-1000 ULTRASONIC A/B SCANNER
K020151 · IYO
Tomey Corp. USA
Radiology · 84d
Cleared Apr 10, 2002
SURGASSIST SYSTEM
K020343 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 68d
Cleared Apr 10, 2002
GREAT GLOVE LATEX EXAMINATION POWDERFREE GLOVES WITH PROTEIN LABELLING CLAIMS...
K020363 · LYY
Great Glove Sdn Bhd
General Hospital · 65d
Cleared Apr 10, 2002
BIOCELLECT -PERIO
K020396 · LYC
Imtec Corp.
Dental · 63d
Cleared Apr 10, 2002
SIMPLICITY EASY SOFT INFUSION SET
K020912 · FPA
Sterling Medivations, Inc.
General Hospital · 21d
Cleared Apr 10, 2002
SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS...
K020990 · FPA
Sterling Medivations, Inc.
General Hospital · 14d
Cleared Apr 09, 2002
MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP
K010281 · DTB
Biotronik, Inc.
Cardiovascular · 434d
Cleared Apr 09, 2002
CARDIOVENTION CORX SYSTEM, MODEL FG 0001
K012325 · KFM
Cardiovention, Inc.
Cardiovascular · 260d
Cleared Apr 09, 2002
URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC...
K012758 · FGB
Circon Video
Gastroenterology & Urology · 235d
Cleared Apr 09, 2002
FRIALOC DENTAL IMPLANT SYSTEM
K013067 · DZE
Friadent GmbH
Dental · 209d
Cleared Apr 09, 2002
ASTRONOMER PLUS SYSTEM
K013349 · DQK
Ep Technologies, Inc.
Cardiovascular · 182d
Cleared Apr 09, 2002
HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER
K014025 · DQA
Hommed, LLC
Anesthesiology · 124d
Cleared Apr 09, 2002
ATHOS LASER
K020072 · GEX
Quantel Medical
General & Plastic Surgery · 90d
Cleared Apr 09, 2002
FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN
K020139 · LPL
Ciba Vision Corporation
Ophthalmic · 83d
Cleared Apr 09, 2002
AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVE
K020376 · EMA
Advanced Healthcare , Ltd.
Dental · 64d