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
89185–89208 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 1998
BALADI INVERTER WITH COAXIAL AORTIC PUNCH
K980128 · DXC
Cardio Medical Solutions, Inc.
Cardiovascular · 191d
Cleared Jul 24, 1998
MOBETRON
K981112 · LHN
Intraop Medical, Inc.
Radiology · 120d
Cleared Jul 24, 1998
OTO WIZZARD
K981511 · EWO
Medrx, Inc.
Ear, Nose, Throat · 87d
Cleared Jul 24, 1998
LIQUID ENZYME ID 90133
K981561 · LPN
Alcon Laboratories
Ophthalmic · 84d
Cleared Jul 24, 1998
BACT/ALERT 3D MICROBIAL DETECTION SYSTEM
K981736 · MDB
Organon Teknika Corp.
Microbiology · 67d
Cleared Jul 24, 1998
CARRIAZO BARRAQUER MICROKERATOME
K981741 · HMY
Moria, Inc.
Ophthalmic · 67d
Cleared Jul 24, 1998
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K981774 · LYY
Pwa Industries Sdn. Bhd.
General Hospital · 65d
Cleared Jul 24, 1998
XENON LIGHT SOURCE MODEL LS6000
K981804 · GCT
Contec Medical Vision, Ltd.
Gastroenterology & Urology · 64d
Cleared Jul 24, 1998
SENSITEX EXAMINATION GLOVE
K981963 · LYZ
Oak Carolina, Inc.
General Hospital · 50d
Cleared Jul 24, 1998
CARESIDE ANALYZER
K982118 · CHH
Exigent Diagnostics, Inc.
Chemistry · 51d
Cleared Jul 23, 1998
ALTRA FLUX 200 HEMODIALYZER
K970679 · MSF
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 514d
Cleared Jul 23, 1998
ALTRA NOVA 200 HEMODIALYZER
K970681 · MSF
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 514d
Cleared Jul 23, 1998
TSX PRM PULMONARY RESUSCITATION MONITOR
K973347 · CAP
Spiracle Technology
Anesthesiology · 321d
Cleared Jul 23, 1998
ML MICROKERATOME
K981071 · HNO
Med-Logics, Inc.
Ophthalmic · 121d
Cleared Jul 23, 1998
TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000
K981078 · CAW
Transtracheal Systems
Anesthesiology · 121d
Cleared Jul 23, 1998
VIPERCAM
K981534 · EIA
Integra Medical
Dental · 85d
Cleared Jul 23, 1998
DENTAL PORCELAIN-VARIOUS
K981708 · FLL
Excel Porcelain Products
General Hospital · 87d
Cleared Jul 23, 1998
CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA...
K982269 · MIA
Allegiance Healthcare Corp.
Anesthesiology · 24d
Cleared Jul 22, 1998
CORE AND COIL ASSEMBLY GUIDEWIRE
K971322 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 468d
Cleared Jul 22, 1998
SANDS SERIES III HYPERBARIC CHAMBER
K972908 · CBF
Sands Hyperbarics
Anesthesiology · 350d
Cleared Jul 22, 1998
UBI MAGIWEL MARIJUANA METABOLITES
K973154 · LDJ
United Biotech, Inc.
Toxicology · 334d
Cleared Jul 22, 1998
SPIROBANK PORTABLE PC BASED SPIROMETER
K973456 · BZG
Futuremed America, Inc.
Anesthesiology · 314d
Cleared Jul 22, 1998
DADE INNOVIN
K974343 · GJS
Dade Intl., Inc.
Hematology · 245d
Cleared Jul 22, 1998
GOODKNIGHT 418 CPAP SYSTEM
K980365 · BZD
Nellcor Puritan Bennett, Inc.
Anesthesiology · 174d