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

Filters: Cleared only ×
176,076 results
80545–80568 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 09, 2001
SONICAID FM820, SONICAID FM830
K002150 · HGM
Oxford Instruments
Obstetrics & Gynecology · 235d
Cleared Mar 09, 2001
OPD-SCAN, MODELS ARK-10000 AND ARK-9000
K003299 · HLQ
Nidek Co., Ltd.
Ophthalmic · 140d
Cleared Mar 09, 2001
CARRIAZO BARRAQUER SINGLE USE MICROKERATOME
K003594 · HMY
Moria, Inc.
Ophthalmic · 108d
Cleared Mar 09, 2001
ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM,...
K003816 · HWC
Arthrex, Inc.
Orthopedic · 88d
Cleared Mar 09, 2001
EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC...
K003867 · NUC
Biofilm, Inc.
Obstetrics & Gynecology · 87d
Cleared Mar 09, 2001
SLEEVED FILTER
K010040 · CAH
King Systems Corp.
General Hospital · 63d
Cleared Mar 09, 2001
VCF PERSONAL LUBRICANT
K010182 · NUC
Apothecus Pharmaceutical Corp.
Obstetrics & Gynecology · 49d
Cleared Mar 09, 2001
MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM
K010367 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 30d
Cleared Mar 09, 2001
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS
K010390 · DXT
Acist Medical Systems, Inc.
Cardiovascular · 28d
Cleared Mar 09, 2001
CENTURA PHOTOTHERAPY SPOTLIGHT
K010495 · LBI
Medical Illumination International, Inc.
General Hospital · 17d
Cleared Mar 09, 2001
TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY
K010505 · DPS
Brentwood Medical Technology Corp.
Cardiovascular · 16d
Cleared Mar 09, 2001
NICOLET VERSALAB
K010521 · JAF
Nicolet Biomedical
Radiology · 15d
Cleared Mar 08, 2001
PERFADEX SOLUTION FOR ORGAN PRESERVATION
K000881 · MSB
Vitrolife Sweden AB
Gastroenterology & Urology · 353d
Cleared Mar 08, 2001
PVS 1300 NEURO GUIDE WIRE
K002907 · DQX
Precision Vascular Systems, Inc.
Cardiovascular · 171d
Cleared Mar 08, 2001
LASER 3 SPSC300
K003058 · INI
Pride Mobility Products Corp.
Physical Medicine · 157d
Cleared Mar 08, 2001
LIFECARE COMPACT TENS DEVICE
K003369 · GZJ
Lifecare , Ltd.
Neurology · 129d
Cleared Mar 08, 2001
NEWTOM QR-DVT 9000
K003787 · OAS
Aperio Services, LLC
Radiology · 90d
Cleared Mar 08, 2001
DISPOSABLE CB-PE MICROKERATOME BLADES
K003820 · HNO
Oasis Medical, Inc.
Ophthalmic · 87d
Cleared Mar 08, 2001
OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI
K003824 · LFL
Omnisonics Medical Technologies
General & Plastic Surgery · 87d
Cleared Mar 08, 2001
FOCUS DAILIES PROGRESSIVES
K003826 · MVN
Ciba Vision Corporation
Ophthalmic · 87d
Cleared Mar 08, 2001
BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT...
K003861 · LPL
Benz Research and Development Corp.
Ophthalmic · 85d
Cleared Mar 08, 2001
SEROJET
K003908 · KZE
Bioject, Inc.
General Hospital · 79d
Cleared Mar 08, 2001
MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12
K004034 · DKZ
Branan Medical Corp.
Toxicology · 70d
Cleared Mar 08, 2001
HERACERAM 75
K010416 · EJT
Jelenko Co.
Dental · 24d