FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
73009–73032 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 04, 2003
STARMATRIX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM
K023715 · LYY
Starmatrix Sdn Bhd
General Hospital · 91d
Cleared Feb 04, 2003
K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP...
K023828 · DCK
Kamiya Biomedical Co.
Immunology · 78d
Cleared Feb 04, 2003
AIROCIDE TI02
K023830 · FRA
Kes Science & Technology, Inc.
General Hospital · 78d
Cleared Feb 04, 2003
GE DISCOVERY LS SYSTEM
K023988 · KPS
GE Medical Systems
Radiology · 64d
Cleared Feb 04, 2003
PANORAMA ENHANCEMENTS
K024042 · LNH
Philips Medical Systems, Inc.
Radiology · 60d
Cleared Feb 04, 2003
INFINION SOFTWARE FEATURES
K024066 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 57d
Cleared Feb 04, 2003
SPIRIT III TOTALSENSE CARDIAC COIL
K024187 · MOS
Usa Instruments, Inc.
Radiology · 47d
Cleared Feb 04, 2003
UP-DF500 FILMSTATION DIGITAL FILM IMAGER
K024188 · LMC
Sony Medical Systems
Radiology · 47d