Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
156265–156288 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 1983
WINDSOR MEDICAL MODEL 52
K832641 · FRN
Windsor Medical, Inc.
General Hospital · 61d
Cleared Oct 04, 1983
ATI FOREHEAD THERMOMETER
K832651 · KPD
American Thermal Instruments, Inc.
General Hospital · 57d
Cleared Oct 04, 1983
DIRECTOR
K832658 · FMF
Pharmacia, Inc.
General Hospital · 57d
Cleared Oct 04, 1983
DENTAL SYRINGE SYSTEM-VARIOUS STYLES
K832662 · KXR
Centrix, Inc.
Dental · 57d
Cleared Oct 04, 1983
SERALYZER TRIGLYCERIDES REAGENT STRIPS
K832684 · CDT
Miles Laboratories, Inc.
Chemistry · 56d
Cleared Oct 04, 1983
LYPHOCHEK SERUM REF. STANDARD-BOVINE
K832695 · JIX
Bio-Rad
Chemistry · 55d
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