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
80449–80472 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 11, 2001
PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES
K002381 · FMF
Pentaferte, S.R.L.
General Hospital · 160d
Cleared Jan 11, 2001
LACTOSORB SCREW ANCHOR
K003273 · MAI
Biomet, Inc.
Orthopedic · 85d
Cleared Jan 11, 2001
FILAC FAS TEMP ELECTRONIC THERMOMETER
K003313 · FLL
The Kendall Company
General Hospital · 80d
Cleared Jan 11, 2001
BURN JEL PLUS
K003396 · MGQ
Water-Jel Technologies, LLC
General & Plastic Surgery · 71d
Cleared Jan 11, 2001
CARE PROVIDER STATION ADDITION OF WEIGHT SCALE
K003485 · DQD
Cybercare Technologies, Inc.
Cardiovascular · 85d
Cleared Jan 11, 2001
TAXOL ADMINISTRATION SET
K003513 · FPA
Icu Medical, Inc.
General Hospital · 58d
Cleared Jan 11, 2001
AVANTE CURELIGHT
K003683 · EBZ
Jeneric/Pentron, Inc.
Dental · 43d
Cleared Jan 11, 2001
HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST
K003848 · JEC
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jan 11, 2001
MULTITRACK ANGIOGRAPHIC CATHETER
K003902 · DQO
NuMED, Inc.
Cardiovascular · 23d
Cleared Jan 11, 2001
NUMED GHOST II PTA CATHETERS
K003972 · LIT
NuMED, Inc.
Cardiovascular · 20d
Cleared Jan 10, 2001
TRIAD II MODULAR TOTAL HIP SYSTEM
K003199 · LPH
Osteoimplant Technology, Inc.
Orthopedic · 90d
Cleared Jan 10, 2001
FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II
K003202 · GEX
Altus Medical
General & Plastic Surgery · 90d
Cleared Jan 10, 2001
U2 HIP STEM, TI POROUS COATED
K003237 · LPH
United Orthopedic Corp.
Orthopedic · 85d
Cleared Jan 10, 2001
BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G,...
K003603 · EJT
Jelenko Co.
Dental · 50d
Cleared Jan 09, 2001
SYNTHES (USA) RESORBABLE TACK SYSTEM
K000560 · JEY
Synthes (Usa)
Dental · 326d
Cleared Jan 09, 2001
VENODYNE DVT ADVANTAGE MODEL 610
K001802 · JOW
Microtek Medical, Inc.
Cardiovascular · 209d
Cleared Jan 09, 2001
PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES
K003072 · DTB
Biotronik, Inc.
Cardiovascular · 98d
Cleared Jan 09, 2001
BARD MEMOTHERM ENDOSCOPIC BILIARY STENT
K003186 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 09, 2001
AUROFILM NP
K003387 · EJH
Metalor Dental USA Corp.
Dental · 70d
Cleared Jan 09, 2001
UNIGRAFT
K003457 · LYC
Unicare Biomedical
Dental · 63d
Cleared Jan 09, 2001
RAPIDD HIGHSPEED DENTAL HANDPIECE
K003518 · EFB
Dentsply Intl.
Dental · 55d
Cleared Jan 09, 2001
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K003619 · LTT
Dade Microscan, Inc.
Microbiology · 48d
Cleared Jan 09, 2001
SHANGHAI CHINA STAR CORP POWDERED BLUE NITRILE PATIENT EXAMINATION GLOVES
K003675 · LZA
Shanghai China Star Corp
General Hospital · 41d
Cleared Jan 08, 2001
KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS
K001896 · DPS
Suzuken Co., Ltd.
Cardiovascular · 201d