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
143305–143328 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 1986
BIOTIS MITIS SALIVARIUS
K862394 · JSI
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS DECARBOXYLASE MEDIA, BASE
K862395 · JSH
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS DECARBOXYLASE MEDIA, ARGININE
K862396 · JSF
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS DECARBOXYLASE MEDIA, LYSINE
K862397 · JSF
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS DECARBOXYLASE MEDIA, ORNITHINE
K862398 · JSF
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS SXT AGAR
K862399 · JSJ
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS KV LAKED BLOOD AGAR
K862400 · JSJ
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
NICKEL,20% CHROMIUM PORCELAIN FUSED TO METAL ALLOY
K862417 · EJH
Austenal Dental, Inc.
Dental · 8d
Cleared Jul 02, 1986
ANTI-LEU-12 B CELL REAGENT
K851639 · LJD
Bd Becton Dickinson Vacutainer...
Hematology · 439d
Cleared Jul 02, 1986
GLUCOMETER M BLOOD GULCOSE METER
K855202 · CGA
Miles Laboratories, Inc.
Chemistry · 188d
Cleared Jul 02, 1986
GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEM
K860782 · LQF
Gen-Probe, Inc.
Microbiology · 121d
Cleared Jul 02, 1986
DIGITAL SUBTRACTION ANGIOGRAPHY CATHETERS AND SETS
K860867 · DQO
Medical Components, Inc.
Cardiovascular · 117d
Cleared Jul 02, 1986
RAMP PROGESTURINE PDG ASSAY--48 TEST KIT
K860924 · JLS
Monoclonal Antibodies, Inc.
Chemistry · 113d
Cleared Jul 02, 1986
GILFORD UNIQUAL ABNORMAL CONTROL SERUM/ASSAYED
K860999 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 106d
Cleared Jul 02, 1986
GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER
K861303 · CGA
Miles Laboratories, Inc.
Chemistry · 86d
Cleared Jul 02, 1986
CLINIFACTS 200 DATA MANAGEMENT SYSTEM
K861778 · JQP
Miles Laboratories, Inc.
Chemistry · 55d
Cleared Jul 02, 1986
V-TREND EIA TSH
K861918 · JLW
V-Tech, Inc.
Chemistry · 44d
Cleared Jul 02, 1986
HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY
K862083 · JHJ
Hygeia Sciences
Chemistry · 30d
Cleared Jul 02, 1986
MODEL 435-02 CARDIFIX IMPLANTABLE PACING LEAD
K862276 · DTB
Intermedics, Inc.
Cardiovascular · 16d
Cleared Jul 02, 1986
SINGLE-USE PATIENT UNDERPAD
K862348 · KME
Procter & Gamble Mfg. Co.
General Hospital · 12d
Cleared Jul 02, 1986
MACCONKEY AGAR W/MUG, DRI-FORM AND PRE-FORM
K862425 · JSI
Gibco Laboratories Life Technologies,...
Microbiology · 6d
Cleared Jul 01, 1986
ELEFIX ELECTRODE CREAM
K860210 · GYB
Nihon Kohden America, Inc.
Neurology · 160d
Cleared Jul 01, 1986
PANASONIC BLOOD PRESSURE METER, ZH-852AP, ZH-858PP
K860634 · DXN
Panasonic Co. Div. Matsu Elec. Corp....
Cardiovascular · 131d
Cleared Jul 01, 1986
CEPHALOSTAT
K860835 · EHD
Dallas Dental Co.
Radiology · 118d