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
140401–140424 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 1987
RESUBMISSION OF THE KLEERZIT REAGENT
K864866 · JKA
Advanced Biomedical Methods, Inc.
Chemistry · 95d
Cleared Mar 16, 1987
MEVACHECK
K864910 · IYE
Magus Microcontrollers, Inc.
Radiology · 91d
Cleared Mar 16, 1987
CYTOSCAN
K864955 · LNJ
Image Recognition Systems , Ltd.
Pathology · 88d
Cleared Mar 16, 1987
IQ FTI IMMUNOASSAY
K865104 · CEC
Bd Becton Dickinson Vacutainer...
Chemistry · 76d
Cleared Mar 16, 1987
HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER
K870027 · CCQ
Salter Labs
Anesthesiology · 70d
Cleared Mar 16, 1987
RMI VENOUS DRAINAGE CANNULA
K870109 · DWF
Research Medical, Inc.
Cardiovascular · 63d
Cleared Mar 16, 1987
(MERIFLUOR)TM-CRYPTOSPORIDIUM
K870171
Meridian Diagnostics, Inc.
Microbiology · 61d
Cleared Mar 16, 1987
ARIES TAPERED SHEATH
K870189 · DYB
Aries Medical, Inc.
Cardiovascular · 59d
Cleared Mar 16, 1987
HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD
K870363 · KHG
Trace Scientific , Ltd.
Hematology · 47d
Cleared Mar 16, 1987
ABUSCREEN (R) EIA CANNABINOIDS
K870377 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 46d
Cleared Mar 16, 1987
ABUSCREEN (R) EIA BARBITURATE
K870378 · DIS
Roche Diagnostic Systems, Inc.
Toxicology · 46d
Cleared Mar 16, 1987
MOBILIMB HAND EXERCISER
K870402 · BXB
Biodynamic Technologies, Inc.
Physical Medicine · 42d
Cleared Mar 16, 1987
GRUNWALD BI-CAVAL & JONES BI-CAVAL CANNULA
K870507 · DWF
Research Medical, Inc.
Cardiovascular · 39d
Cleared Mar 16, 1987
CHART-TYPE MICRO HEMATOCRIT TUBE READER
K870511 · JPI
Norfolk Scientific, Inc.
Hematology · 39d
Cleared Mar 16, 1987
ACCELOGRAPH
K870619 · BXN
Biometer Intl. A/S
Anesthesiology · 32d
Cleared Mar 16, 1987
CHALLENGER DOSIMETER
K870755 · CCQ
Salter Labs
Anesthesiology · 18d
Cleared Mar 16, 1987
BODYSCAN
K870818 · IYX
Siemens Gammasonics, Inc.
Radiology · 13d
Cleared Mar 13, 1987
SHBG IRMA KIT
K861679 · CDZ
Farmos Group , Ltd.
Chemistry · 316d
Cleared Mar 13, 1987
EPISON, ALERTING SYSTEM FOR EPILEPTICS
K862766 · LEL
Zygo Industries, Inc.
Neurology · 234d
Cleared Mar 13, 1987
SYVA ETS SYSTEM
K863245 · JJF
Syva Co.
Chemistry · 203d
Cleared Mar 13, 1987
UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUALITATIVE
K864174 · JHI
United Biotech, Inc.
Chemistry · 140d
Cleared Mar 13, 1987
CO2 REAGENT SET
K864313 · CIE
Hf Scientific, Inc.
Chemistry · 130d
Cleared Mar 13, 1987
RING UPM TOTAL HIP REPLACEMENT
K864515 · KWA
Downs Surgical , Ltd.
Orthopedic · 116d
Cleared Mar 13, 1987
SUNGLASSES
K864543 · HQY
Image of Hawaii
Ophthalmic · 114d