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
73609–73632 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 06, 2003
OLYMPUS FERRITIN REAGENT
K030124 · DBF
Olympus America, Inc.
Immunology · 23d
Cleared Feb 06, 2003
SONOCALC
K030223 · LLZ
Sonometric Health, LLC
Radiology · 15d
Cleared Feb 05, 2003
REPROCESSED COMPRESSION SLEEVE
K021654 · JOW
Alliance Medical, Inc.
Cardiovascular · 261d
Cleared Feb 05, 2003
OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM
K022877 · LLZ
Vision Chips, Inc.
Radiology · 159d
Cleared Feb 05, 2003
SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1
K022959 · EJI
MDC Research , Ltd.
Dental · 152d
Cleared Feb 05, 2003
FRIOS ALGIPORE
K023799 · LYC
Friadent GmbH
Dental · 83d
Cleared Feb 05, 2003
SMALL TITANIUM WRIST FUSION PLATE
K023879 · HRS
Synthes (Usa)
Orthopedic · 76d
Cleared Feb 05, 2003
JET-X HA COATED HALF PINS
K023921 · JDW
Smith & Nephew, Inc.
Orthopedic · 72d
Cleared Feb 05, 2003
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP...
K023946 · DIS
ACON Laboratories, Inc.
Toxicology · 70d
Cleared Feb 05, 2003
ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ
K023994 · MNH
Ortho Tec, LLC
Orthopedic · 64d
Cleared Feb 05, 2003
GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT...
K024003 · LPL
Gelflex
Ophthalmic · 63d
Cleared Feb 05, 2003
NESS CHILDREN SYSTEM
K024279 · IPG
Ness-Neuromuscular Electrical...
Physical Medicine · 44d
Cleared Feb 05, 2003
UNIVERSAL TOTAL WRIST SYSTEM
K030037 · JWJ
Kinetikos Medical, Inc.
Orthopedic · 30d
Cleared Feb 05, 2003
HA PMI FEMORAL HIP STEM
K030048 · LPH
Biomet Orthopedics, Inc.
Orthopedic · 30d
Cleared Feb 05, 2003
SPINEMED
K030060 · ITH
Cert Health Sciences, LLC
Physical Medicine · 29d
Cleared Feb 05, 2003
VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS
K030079 · LPH
Zimmer, Inc.
Orthopedic · 27d
Cleared Feb 05, 2003
CARDIUS-1 AND CARDIS-2
K030085 · KPS
Digirad Corp.
Radiology · 27d
Cleared Feb 05, 2003
SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS
K030103 · MNI
Depuyacromed
Orthopedic · 23d
Cleared Feb 05, 2003
DEPUY SUMMIT BASIC PRESS-FIT HIP STEM
K030122 · LWJ
DePuy Orthopaedics, Inc.
Orthopedic · 22d
Cleared Feb 04, 2003
DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3
K014001 · MQN
Oral Osteodistraction, L.P.
Dental · 427d
Cleared Feb 04, 2003
NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200
K022364 · HAW
Orthosoft, Inc.
Neurology · 197d
Cleared Feb 04, 2003
HTS COIL
K022863 · MOS
Jockey Club Mri Engineering Center
Radiology · 160d
Cleared Feb 04, 2003
TRUTEK SELECT MODEL TT-1001
K023510 · FLL
Trutek, Inc.
General Hospital · 106d
Cleared Feb 04, 2003
SNAP KOVER, MODEL 01-2020
K023540 · MMP
Valumed
General Hospital · 105d