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
89113–89136 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 1998
VITA TITANIUM PORCELAIN
K982664 · EIH
Vident
Dental · 2d
Cleared Jul 31, 1998
IMAGEQUEST
K974707 · LMD
Visual Med, Inc.
Radiology · 227d
Cleared Jul 31, 1998
EPIDURAL NEEDLE
K980536 · BSP
Manan Medical Products, Inc.
Anesthesiology · 170d
Cleared Jul 31, 1998
CALM
K980719 · HGM
Lms Medical Systems , Ltd.
Obstetrics & Gynecology · 157d
Cleared Jul 31, 1998
POLYCARBOXYLATE CEMENT
K980990 · EMA
Medental Intl.
Dental · 136d
Cleared Jul 31, 1998
HARMONIC IMAGING AND FLASH ECHO IMAGING FUNCTION FOR THE DIAGNOSTIC...
K981397 · IYN
Toshiba America Medical Systems, In.C
Radiology · 105d
Cleared Jul 31, 1998
ULTRAPAK E
K981596 · MVL
Ultradent Products, Inc.
Dental · 88d
Cleared Jul 31, 1998
MTA MATERIAL II
K981620 · KIF
Dentsply Intl.
Dental · 86d
Cleared Jul 31, 1998
PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE)
K981627 · GEX
Xintec Corporation
General & Plastic Surgery · 85d
Cleared Jul 31, 1998
CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET...
K981713 · MGP
Smith & Nephew, Inc.
General & Plastic Surgery · 77d
Cleared Jul 31, 1998
WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE
K981889 · FCG
Worldwide Medical Technologies, LLC
Gastroenterology & Urology · 63d
Cleared Jul 31, 1998
OUTLOOK LARGE PHASED ARRAY NECK COIL
K981959 · MOS
Philips Medical Systems (Cleveland),...
Radiology · 57d
Cleared Jul 31, 1998
PRODIGY 2
K982148 · EBF
Sybron Dental Specialties, Inc.
Dental · 43d
Cleared Jul 31, 1998
IMPLEX CONTINUUM KNEE - HEDROCEL TIBIAL SPACERS
K982302 · JWH
Implex Corp.
Orthopedic · 30d
Cleared Jul 31, 1998
MANIFOLD WITH EXTENSION SET
K982368 · FMG
Interpore Cross Intl.
General Hospital · 24d
Cleared Jul 31, 1998
IMAGYN 125 I SEED, MODEL IS 125
K982421 · IWG
International Isotopes, Inc.
Radiology · 18d
Cleared Jul 31, 1998
GENESIS IMRT LINEAR ACCELERATOR
K982502 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 11d
Cleared Jul 31, 1998
MX MEVATRON
K982513 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 11d
Cleared Jul 30, 1998
MACROPORE PROTECTIVE SHEET (PROTEGO SYSTEM)
K972913 · HRS
Pacific Materials and Interfaces
Orthopedic · 357d
Cleared Jul 30, 1998
DIPSTREAK
K974428 · JSI
Novamed , Ltd.
Microbiology · 248d
Cleared Jul 30, 1998
SENSOREX BLOOD GLUCOSE MONITORING SYSTEM
K980573 · CGA
Chronimed, Inc.
Chemistry · 163d
Cleared Jul 30, 1998
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM
K980821 · LYR
Zeus Scientific, Inc.
Microbiology · 149d
Cleared Jul 30, 1998
PYLORIPROBE
K981396 · LYR
Amdl, Inc.
Microbiology · 104d
Cleared Jul 30, 1998
SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT
K981562 · EBF
Sulzer Calcitek, Inc.
Dental · 90d