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
155041–155064 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 1983
ANGIOSCOPY CATHETER
K832698 · LYK
American Edwards Laboratories
Cardiovascular · 85d
Cleared Nov 03, 1983
STARLYTE
K832744 · JGS
Electro-Nucleonics Laboratories, Inc.
Chemistry · 80d
Cleared Nov 03, 1983
INFUSION PUMP & IV SETS #4000
K832755 · FRN
Omni-Glow, Inc.
General Hospital · 79d
Cleared Nov 03, 1983
ADVANTAGE #1700
K832767 · CCK
The Perkin-Elmer Corp.
Anesthesiology · 79d
Cleared Nov 03, 1983
SATURN-24HR. HOLTER SCANNER
K832772 · DSI
Hittman Medical Systems
Cardiovascular · 79d
Cleared Nov 03, 1983
CORPULS 300
K832827 · LDD
Automated Medical Products, Inc.
Cardiovascular · 73d
Cleared Nov 03, 1983
HEMO-DIAL
K832866 · KPO
Cmi Pharmaceuticals, Inc.
Gastroenterology & Urology · 72d
Cleared Nov 03, 1983
PREGNA-TEC
K832918 · JHJ
Medilab Corp.
Chemistry · 70d
Cleared Nov 03, 1983
AMBULATORY INSULIN INFUSION PUMP
K832923 · FRN
Caridac Pacemakers, Inc.
General Hospital · 71d
Cleared Nov 03, 1983
SERUM IRON & TIBC#65084 & 65085
K833017 · JIY
Emd Chemicals, Inc.
Chemistry · 58d
Cleared Nov 03, 1983
TECHNICON RA-1000 SYSTEM
K833023 · JJC
Technicon Instruments Corp.
Chemistry · 58d
Cleared Nov 03, 1983
INTRAVASCULAR ADMINISTRATION SET
K833030 · FPA
Gish Biomedical, Inc.
General Hospital · 57d
Cleared Nov 03, 1983
CALCIUM DYE REAGENT-CS-718-A/BUFFER
K833035 · CIC
Fisher Scientific Co., LLC
Chemistry · 57d
Cleared Nov 03, 1983
MODEL CD-3A-INCLUDING P-61B SENSOR
K833060 · CCK
Applied Electrochemistry, Inc.
Anesthesiology · 56d
Cleared Nov 03, 1983
TRANSDUCER DOME SD104
K833094 · DRS
Sorensen Research
Cardiovascular · 52d
Cleared Nov 03, 1983
TRANSDUCER DOME SD105
K833095 · DRS
Sorensen Research
Cardiovascular · 52d
Cleared Nov 03, 1983
TRANSDUCER DOME DS106
K833096 · DRS
Sorensen Research
Cardiovascular · 52d
Cleared Nov 03, 1983
ARGYLE NASAL CANNULA
K833127 · CAT
Sherwood Medical Co.
Anesthesiology · 51d
Cleared Nov 03, 1983
VOLUME VENTILATOR CIRCUIT-NEBULIZER
K833196 · CAI
Airlife, Inc.
Anesthesiology · 45d
Cleared Nov 03, 1983
ADLER STEAM INDICATOR-GAS INDICATOR
K833264 · JOJ
Adler Instrument Co.
General Hospital · 44d
Cleared Nov 03, 1983
THROMBOPLASTIN - FS
K833272 · JPA
American Dade
Hematology · 43d
Cleared Nov 03, 1983
BIO-REX 70 RESIN 100-200 MESH PH6.2
K833319 · KEA
Biosan Laboratories, Inc.
Toxicology · 38d
Cleared Nov 03, 1983
MINI OX III OXYGEN MONITOR
K833326 · BXL
Catalyst Research Corp.
Anesthesiology · 37d
Cleared Nov 03, 1983
STERILIZATION CONTAINER
K833343 · FRG
Medin Corp.
General Hospital · 37d