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
124465–124488 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 07, 1990
MEDI MODEL SBL502-B (LISS BODY STIMULATOR) ZERO DC
K902976 · GZL
Medical Consultants Intl. , Ltd.
Neurology · 63d
Cleared Sep 07, 1990
MILENIA (TM) AMPHETAMINE
K902979 · DKZ
Diagnostic Products Corp.
Chemistry · 67d
Cleared Sep 07, 1990
MRP-20: SUPPL R/F COIL HS/MR QUADRATURE HEAD COIL
K903204 · LNH
Summit World Trade Corp.
Radiology · 49d
Cleared Sep 07, 1990
ROCHE COBAS READY AMYLASE REAGENT
K903309 · JFJ
Roche Diagnostic Systems, Inc.
Chemistry · 45d
Cleared Sep 07, 1990
CHALLENGE(TM) BRAND LIQ MULTI-ANALYTE LINEAR CONTR
K903310 · JJY
Medical Analysis Systems, Inc.
Chemistry · 45d
Cleared Sep 07, 1990
NOVAPATH TSH ENZYME IMMUNOASSAY
K903311 · JLW
Bio-Rad
Chemistry · 45d
Cleared Sep 07, 1990
UREA NITROGEN TEST
K903334 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 44d
Cleared Sep 07, 1990
KENLOR THERAPEUTIC DRUG MONITORING (TDM) CONTROL
K903338 · JJY
Kenlor Industries, Inc.
Chemistry · 44d
Cleared Sep 07, 1990
AFFINITY HLH TEST SYSTEM
K903407 · JJY
Bd Becton Dickinson Vacutainer...
Chemistry · 38d
Cleared Sep 07, 1990
IMX FREE T3 CALCULATION
K903432 · CDP
Abbott Laboratories
Chemistry · 38d
Cleared Sep 07, 1990
LABELLING CHANGES TO IMPRES-MB-X
K903508 · JHW
Intl. Immunoassay Laboratories, Inc.
Chemistry · 38d
Cleared Sep 07, 1990
SYNERMED TOTAL PROTEIN REAGENT KIT
K903511 · CEK
Synermed, Inc.
Chemistry · 35d
Cleared Sep 07, 1990
CURITY THORACENTESIS TRAY
K903569 · JOL
Kendall Healthcare Products Co....
General Hospital · 31d
Cleared Sep 07, 1990
REFLOTRON CREATININE TEST TABS
K903573 · JFY
Boehringer Mannheim Corp.
Chemistry · 31d
Cleared Sep 07, 1990
AIA-PACK IRI
K903628 · CFP
Tosoh Corp.
Chemistry · 28d
Cleared Sep 07, 1990
FUKUDA DENSHI MODEL FCP-2201 MODIFICATION
K903704 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 87d
Cleared Sep 07, 1990
ECT (EMMISSION COMPUTED TOMOGRAPHY) CARBON FIB PAL
K903767 · IYZ
Siemens Gammasonics, Inc.
Radiology · 18d
Cleared Sep 07, 1990
THE ON-GARD CORD-CADDY
K903855 · GEI
On-Gard Systems, Inc.
General & Plastic Surgery · 17d
Cleared Sep 06, 1990
PROPHY PASTE
K901580 · EJR
Dentsply Intl.
Dental · 155d
Cleared Sep 06, 1990
DEGUFLEX MONOPHASE
K901865 · ELW
Degussa AG
Dental · 135d
Cleared Sep 06, 1990
DEGUFLEX (R) CS PUTTY
K901867 · ELW
Degussa AG
Dental · 135d
Cleared Sep 06, 1990
LUHR MICRO MESH
K901940 · JEY
Howmedica Corp.
Dental · 129d
Cleared Sep 06, 1990
LUHR MANDIBULAR COMPRESSION/RECONSTRUCTION PLATES
K901941 · JEY
Howmedica Corp.
Dental · 129d
Cleared Sep 06, 1990
DISPOSABLE BIOPSY FORCEP FOR FLEXIBLE ENDOSCOPES
K902066 · KNW
Endo-Scientific, Inc.
Gastroenterology & Urology · 121d