FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
93409–93432 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 1997
RADIUS PTCA GUIDEWIRE
K970466 · LIT
Radius Medical Technologies, Inc.
Cardiovascular · 102d
Cleared May 20, 1997
OUR ROTATING GAMMA SYSTEM
K970647 · IWB
Our Scientific Intl., Inc.
Radiology · 89d
Cleared May 20, 1997
LOCKING STYLET 2
K970690 · DQX
Cook Pacemaker Corp.
Cardiovascular · 84d
Cleared May 20, 1997
ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)
K970873 · HMX
American Medical Devices, Inc.
Ophthalmic · 71d
Cleared May 20, 1997
ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)
K970875 · MPA
American Medical Devices, Inc.
Ophthalmic · 71d
Cleared May 20, 1997
HOWTEK 960
K970908 · LMA
Howtek, Inc.
Radiology · 70d
Cleared May 20, 1997
SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITOR
K970999 · JAK
Sony Medical Systems
Radiology · 62d
Cleared May 20, 1997
SAFE-T-CLAMP
K971277 · KNA
Talon Medical, Ltd.
Obstetrics & Gynecology · 43d
Cleared May 20, 1997
JEL-71 PDF
K971292 · EJT
J.F. Jelenko & Co., Inc.
Dental · 43d
Cleared May 20, 1997
VISTA SINGLE CHIP VIDEO CAMERA
K971373 · FET
Vista Medical Technologies, Inc.
Gastroenterology & Urology · 36d
Cleared May 20, 1997
UMI X-RAY FILM CASSETTE
K971431 · IXA
Umi Intl.
Radiology · 33d
Cleared May 20, 1997
PROSPORE
K971432 · FRC
Raven Biological Laboratories, Inc.
General Hospital · 33d
Cleared May 20, 1997
CLARUS MODEL 5197 SIGHTLITE
K971455 · FTI
Clarus Medical Systems, Inc.
Gastroenterology & Urology · 29d
Cleared May 20, 1997
PROMED 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS...
K971515 · LPL
Biomed Devices Corp.
Ophthalmic · 25d
Cleared May 20, 1997
JELBOND-PDF
K971574 · EJT
J.F. Jelenko & Co., Inc.
Dental · 43d
Cleared May 19, 1997
KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS)
K962753 · DZE
Biomedical Implant Technology, Inc.
Dental · 308d
Cleared May 19, 1997
MEGA ME 3000 PROFESSIONAL MUSCLE TESTER
K963202 · HCC
Mega Electronics , Ltd.
Neurology · 277d
Cleared May 19, 1997
FREEDOM TRAVELLER
K964825 · MLW
Impact Case Technologies, Inc.
Gastroenterology & Urology · 168d
Cleared May 19, 1997
VIEWPOINT - 3.0 SOFTWARE
K970604 · HAW
Philips Medical Systems (Cleveland),...
Neurology · 90d
Cleared May 19, 1997
BC THROMBIN REAGENT
K970645 · GJA
Behring Diagnostics, Inc.
Hematology · 88d
Cleared May 19, 1997
LUMBAR DRAINAGE ACCESSORY KIT
K970658 · JXG
Integra Neurocare, LLC
Neurology · 87d
Cleared May 19, 1997
GALILEO HALLEY
K970703 · GWQ
Biosound Esaote, Inc.
Neurology · 82d
Cleared May 19, 1997
GRASS BRAINWAVE SOFTWARE
K970951 · OLV
Astro-Med, Inc.
Neurology · 66d
Cleared May 19, 1997
WHITE RIVER MINI MANUAL BREAST PUMP
K971231 · HGY
White River Concepts
Obstetrics & Gynecology · 46d