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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
163009–163032 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 1981
DC-1 CARDIAC IMAGING MODULE
K811556 · DXK
Diasonics, Inc.
Cardiovascular · 38d
Cleared Jul 10, 1981
VENTRE/SEP IGE RIA TEST SET
K811559 · DGC
Ventrex Laboratories, Inc.
Chemistry · 38d
Cleared Jul 10, 1981
SIEMENS ANGIOTRON
K811587 · IXO
Siemens Corp.
Radiology · 35d
Cleared Jul 10, 1981
B-D DRAKE WILLOCK #7000 SERIES ULTRAF
K811591 · FKP
Bd Becton Dickinson Vacutainer...
Chemistry · 32d
Cleared Jul 10, 1981
PREP-SITE PROTECTIVE DRESSING WIPE
K811625 · KMF
Acme United Corp.
General & Plastic Surgery · 31d
Cleared Jul 10, 1981
CIRAS ULTRASONIC SCANNING SYSTEM
K811633 · IYO
Ausonics Pty , Ltd.
Radiology · 31d
Cleared Jul 10, 1981
DATASCOPE INTERNAL DEFIBRILLATOR PADDLES
K811638 · LDD
Datascope Corp.
Cardiovascular · 30d
Cleared Jul 10, 1981
STERI-LOK DUAL PURPOSE PACKAGING/8400
K811670 · FRG
3M Company
General Hospital · 25d
Cleared Jul 10, 1981
GAMBRO WATER PURIFICATION MONITOR WRD
K811678 · FIP
Gambro, Inc.
Gastroenterology & Urology · 25d
Cleared Jul 10, 1981
SILASTIC TENDON PASSER H.P.
K811679 · HWQ
Dow Corning Corp. Healthcare...
Orthopedic · 25d
Cleared Jul 10, 1981
CIRCUIT, BREATHING
K811700 · CAI
Marquest Medical Products, Inc.
Anesthesiology · 24d
Cleared Jul 10, 1981
QUANTIMUNE ESTRIOL RIA
K811709 · CGI
Bio-Rad
Chemistry · 23d
Cleared Jul 10, 1981
HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT
K811714 · DHN
Scripps-Miles, Inc.
Immunology · 23d
Cleared Jul 10, 1981
2M 9810 MICROWAVE OVEN
K811724 · LHF
Travenol Laboratories, S.A.
General Hospital · 22d
Cleared Jul 10, 1981
TBG DIAGNOSTIC KIT
K811725 · CEF
Immuno Assay Corp.
Chemistry · 22d
Cleared Jul 10, 1981
LEKSELL STEREOACTIC SYSTEM
K811726 · LHF
Downs Surgical , Ltd.
Radiology · 22d
Cleared Jul 10, 1981
ENTRI ENTERAL FEEDING PUMP
K811739 · FRN
Biosearch Medical Products, Inc.
General Hospital · 21d
Cleared Jul 10, 1981
VIRGO IPA FOR DETECTION OF GENTAMICIN
K811744 · LCD
Electro-Nucleonics Laboratories, Inc.
Toxicology · 21d
Cleared Jul 10, 1981
VIRGO IPA FOR DETECTION OF PHENYTOIN
K811745 · DIP
Electro-Nucleonics Laboratories, Inc.
Toxicology · 21d
Cleared Jul 10, 1981
KING DIAGNOSTICS CHOLESTEROL-FE TEST
K811746 · CHO
King Diagnostics, Inc.
Chemistry · 18d
Cleared Jul 10, 1981
KING DIAGNOSTICS CHOLESTEROL TEST
K811747 · CGO
King Diagnostics, Inc.
Chemistry · 18d
Cleared Jul 10, 1981
KING DIAGNOSTICS CALCIUM TEST
K811748 · CIC
King Diagnostics, Inc.
Chemistry · 18d
Cleared Jul 10, 1981
KING DIAGNOSTICS PHOSPHORUS TEST
K811749 · CEO
King Diagnostics, Inc.
Chemistry · 18d
Cleared Jul 10, 1981
CHOLESTEROL DETERMINATION
K811760 · CHH
Biorent Diagnostic, Inc.
Chemistry · 18d