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
155425–155448 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 1983
SENSITIVE EYES
K832706 · HPX
Bausch & Lomb, Inc.
Ophthalmic · 53d
Cleared Oct 04, 1983
VITAMIN B12 RADIOASSAY KIT CA-1534
K832710 · CDD
Clinical Assays, Inc.
Chemistry · 53d
Cleared Oct 04, 1983
VITAMIN B12 FOLATE CA-1515-125
K832711 · CDD
Clinical Assays, Inc.
Chemistry · 53d
Cleared Oct 04, 1983
FOLATE RADIOASSAY KIT CA-1562-125
K832712 · CGN
Clinical Assays, Inc.
Chemistry · 53d
Cleared Oct 04, 1983
ENCORE CHEMISTRY ANALYZER
K832716 · JJG
Baker Instructions Corp.
Chemistry · 53d
Cleared Oct 04, 1983
EMIT AED VALPROIC ACID ASSAY
K832719 · LEG
Syva Co.
Toxicology · 53d
Cleared Oct 04, 1983
EMIT AED CARBAMAZEPINE ASSAY
K832720 · KLT
Syva Co.
Toxicology · 53d
Cleared Oct 04, 1983
ELECATH HEPARIN COATED THERMAL DILUTION
K832787 · KYG
Electro-Catheter Corp.
Ophthalmic · 49d
Cleared Oct 04, 1983
NEO-FLOAT NEONATAL FLOTATION SYS & RHYT
K832829 · IOQ
Clinical Data Instruments, Inc.
Physical Medicine · 46d
Cleared Oct 04, 1983
CHEMONUCLEOLYSIS TABLE #6100
K832848
Kirschner Medical Corp.
General & Plastic Surgery · 43d
Cleared Oct 04, 1983
FETAL MONITOR #FM-2
K832849 · HGM
Advantage Medical Systems, Inc.
Obstetrics & Gynecology · 43d
Cleared Oct 04, 1983
GINGI CURETTAGE DIAMOND POINTS
K832856 · DZP
Shofu Dental Corp.
Dental · 42d
Cleared Oct 04, 1983
ELECTRONIC UNIT
K832887 · EPT
Surgi-Quip Inc.U
General & Plastic Surgery · 39d
Cleared Oct 04, 1983
MODEL 329T PROGRAMMABLE, BIPOLAR CARDI
K832893 · DXY
Cook Pacemaker Corp.
Cardiovascular · 39d
Cleared Oct 04, 1983
I-GLIDE IOL IMPLANTATION AID
K832939 · KYB
I For M, Inc.
Ophthalmic · 35d
Cleared Oct 04, 1983
SANODENT DOUBLE-ENDED INTERDENTAL CLEAN
K832949 · JET
Coopercare, Inc.
Dental · 32d
Cleared Oct 04, 1983
MILLIPORE IVEX INT FILTER UNIT
K832952 · FPB
Millipore Corp.
General Hospital · 36d
Cleared Oct 04, 1983
FREEMAN ACETABULAR CUP
K832958 · JDI
Depuy, Inc.
Orthopedic · 35d
Cleared Oct 04, 1983
EPA AUTOMATED INFUSION POLE
K832997 · HQC
Miami Eye Technology, Inc.
Ophthalmic · 32d
Cleared Oct 04, 1983
SUMMA DISK
K833038 · DZP
Shofu Dental Corp.
Dental · 28d
Cleared Oct 04, 1983
HANDY IIM
K833039 · EJP
Shofu Dental Corp.
Dental · 28d
Cleared Sep 29, 1983
PZ-800 VOLUME VENTILATOR
K822835 · CBK
Narco Scientific
Anesthesiology · 373d
Cleared Sep 29, 1983
MMS ACETABULAR CUPS
K830361 · JDI
3M Company
Orthopedic · 238d
Cleared Sep 29, 1983
ELASTOPLAST T.P.N.
K831439 · FPX
Beiersdorf, Inc.
General & Plastic Surgery · 147d