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
163585–163608 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 1981
THE SCOTT DIALMENZENSERT
K810915 · KOA
Lone Star Medical Products, Inc.
Gastroenterology & Urology · 32d
Cleared May 08, 1981
SCANEL 100
K810945 · IYO
Cgr Medical Corp.
Radiology · 31d
Cleared May 08, 1981
ABNORMAL GLYCOSYLATED HEMOGLOBIN CONTROL
K811000 · LCP
Corning Medical & Scientific
Hematology · 25d
Cleared May 08, 1981
MANIFOLD
K811004 · DTZ
American Pharmaseal Div. Ahsc
Cardiovascular · 25d
Cleared May 08, 1981
LUTEINIZING HORMONE DIRECT RIA KIT 125/I
K811024 · CEP
Immunalysis Corporation
Chemistry · 23d
Cleared May 08, 1981
DRESSING TRAY MERCY HOSPITAL
K811088 · LDQ
Cunningham Woodland, Inc.
General & Plastic Surgery · 17d
Cleared May 08, 1981
ONE STEP PREP KIT
K811089 · LDQ
Cunningham Woodland, Inc.
General & Plastic Surgery · 17d
Cleared May 08, 1981
MAJOR DRESSING TRAY
K811090 · LDQ
Cunningham Woodland, Inc.
General & Plastic Surgery · 17d
Cleared May 08, 1981
MINOR DRESSING TRAY
K811091 · LDQ
Cunningham Woodland, Inc.
General & Plastic Surgery · 17d
Cleared May 08, 1981
AUTOMATIC ELISA READER
K811111 · JJQ
Artek Systems Corp.
Chemistry · 15d
Cleared May 08, 1981
AIM SYSTEM (FOR IGM)
K811124 · DFT
Icl Scientific
Immunology · 14d
Cleared May 08, 1981
AIM SYSTEM (FOR IGA)
K811125 · CZP
Icl Scientific
Immunology · 14d
Cleared May 08, 1981
AIM SYSTEM (FOR IGG)
K811126 · DEW
Icl Scientific
Immunology · 14d
Cleared May 08, 1981
FLOWLOCK OXYGEN METER
K811162 · BYJ
Lifeguard Medical Products, Inc.
Anesthesiology · 10d
Cleared May 08, 1981
THREE MODELS OF TABLES, STOOLS, & LIGHTS
K811190 · LGX
Midmark Corp.
General Hospital · 9d
Cleared May 06, 1981
DATASCOPE PERCOR=DL DUAL-LUMEN INTRA
K810297 · DSP
Datascope Corp.
Cardiovascular · 90d
Cleared May 05, 1981
SELECT-A-FLOW COLLECTOR
K810645 · KNX
Wenmar Intl. Corp.
Gastroenterology & Urology · 56d
Cleared May 05, 1981
DISPOSABLE SCRUB BRUSH
K810655 · GEC
Dexide, Inc.
General & Plastic Surgery · 63d
Cleared May 05, 1981
MOUTHPIECE, BREATHING
K810793 · BYP
Dhd Medical Products Div. Diemolding...
Anesthesiology · 43d
Cleared May 05, 1981
RUBAZYME - M
K810835 · GOK
Abbott Laboratories
Immunology · 41d
Cleared May 05, 1981
CYBER 80 HEMODIALYZER
K810837 · FJG
Cyberex Corp.
Gastroenterology & Urology · 40d
Cleared May 05, 1981
DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT
K810856 · GPT
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 36d
Cleared May 05, 1981
ENI ANTIBODY TO EPSTEIN-BARR VIRUS
K810860 · GNP
Electro-Nucleonics Laboratories, Inc.
Microbiology · 36d
Cleared May 05, 1981
TECHNICON AUTOGROUPER 16-C SYSTEM
K810899 · KSZ
Technicon Instruments Corp.
Hematology · 32d