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
92281–92304 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 1997
THE PERIOSEAL DENTAL IMPLANT
K965032 · DZE
Perioseal
Dental · 246d
Cleared Aug 20, 1997
DM-400 HOLTER ECG CASSETTE RECORDER
K970298 · DSH
Diagnostic Monitoring
Cardiovascular · 205d
Cleared Aug 20, 1997
MYCOPLASMA IGM ELISA TEST SYSTEM
K971503 · LJZ
Zeus Scientific, Inc.
Microbiology · 118d
Cleared Aug 20, 1997
IMMUNOCARD STAT! ROTAVIRUS
K971585 · LIQ
Meridian Diagnostics, Inc.
Microbiology · 111d
Cleared Aug 20, 1997
CLARITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971638 · JTN
Oxoid , Ltd.
Microbiology · 110d
Cleared Aug 20, 1997
ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR CORD
K971677 · GEI
Transamerican Technologies Intl.
General & Plastic Surgery · 105d
Cleared Aug 20, 1997
ASSET APOLLO
K971884 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 90d
Cleared Aug 20, 1997
KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM
K971894 · LMA
Eastman Kodak Company
Radiology · 90d
Cleared Aug 20, 1997
JEJENOSTOMY FEEDING TUBE
K971906 · FPD
Boston Scientific Corp
Gastroenterology & Urology · 89d
Cleared Aug 20, 1997
SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT
K971958 · DDG
Beckman Instruments, Inc.
Immunology · 84d
Cleared Aug 20, 1997
EBI SPINELINK SYSTEM
K971970 · MNH
Electro-Biology, Inc.
Orthopedic · 83d
Cleared Aug 20, 1997
OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS
K972303 · LPL
Ocular Sciences Puerto Rico, Inc.
Ophthalmic · 62d
Cleared Aug 20, 1997
MEDNEXT 1000 DRILL
K972308 · GEY
Mednext, Inc.
General & Plastic Surgery · 61d
Cleared Aug 20, 1997
NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A...
K972310 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 61d
Cleared Aug 20, 1997
INNERWEAR, JIMMY-O RAINCOAT, RAINCOAT, JASMINE, DRINK
K972427 · HIS
Custom Services Intl., Inc.
Obstetrics & Gynecology · 54d
Cleared Aug 20, 1997
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL
K972448 · JSL
Copan Italia Spa
Microbiology · 51d
Cleared Aug 20, 1997
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL
K972449 · JSL
Copan Italia Spa
Microbiology · 51d
Cleared Aug 20, 1997
PASCO MIC AND MIC/ID PANELS
K972567 · JWY
Pasco Laboratories, Inc.
Microbiology · 50d
Cleared Aug 20, 1997
QUIKSTRIP ONE STEP OPIATES TEST
K972571 · DJG
Drial Consultants, Inc.
Toxicology · 41d
Cleared Aug 20, 1997
QUICK SCREEN ONE STEP AMPHETAMINE TEST
K972577 · DIT
Phamatech
Toxicology · 41d
Cleared Aug 20, 1997
QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080)
K972619 · DJG
Phamatech
Toxicology · 40d
Cleared Aug 20, 1997
AVL 9181 ELECTROLYTE ANALYZER
K972673 · JFP
Avl Scientific Corp.
Chemistry · 35d
Cleared Aug 19, 1997
REGULUS NAVIGATOR
K964229 · HAW
Compass Intl., Inc.
Neurology · 300d
Cleared Aug 19, 1997
NIAGARA DUAL LUMEN CATHETER
K965178 · MPB
Vas-Cath, Inc.
Gastroenterology & Urology · 238d