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
161713–161736 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 1981
DISS FEMALE AIR ADAPTOR
K813235 · BYK
Timeter Instrument Corp.
Anesthesiology · 21d
Cleared Dec 08, 1981
UV URIC ACID DETERMINATION
K813244 · CDO
Biorent Diagnostic, Inc.
Chemistry · 20d
Cleared Dec 08, 1981
CONPHAR DELEE HILLIS STETHOSCOPE
K813298 · HGN
Conphar, Inc.
Obstetrics & Gynecology · 15d
Cleared Dec 03, 1981
LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER
K812744 · HAW
Progress Mankind Technology
Neurology · 65d
Cleared Dec 03, 1981
INFANT PERCUSSOR #5534
K812803 · BYI
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 58d
Cleared Dec 03, 1981
MICROCOIL 80 DIALYZER
K812811 · FHS
Erika, Inc.
Gastroenterology & Urology · 58d
Cleared Dec 03, 1981
CREATININE REAGENT SET
K812834 · CGX
Anco Medical Reagents & Assoc.
Chemistry · 55d
Cleared Dec 03, 1981
TRIGLYCERIDE REAGENT SET
K812838 · CDT
Anco Medical Reagents & Assoc.
Chemistry · 55d
Cleared Dec 03, 1981
HDL CHOLESTEROL REAGENT SET
K812839 · LBR
Anco Medical Reagents & Assoc.
Chemistry · 55d
Cleared Dec 03, 1981
SERUM IRON REAGENT SET
K812840 · JIY
Anco Medical Reagents & Assoc.
Chemistry · 55d
Cleared Dec 03, 1981
PTT-200 TELEPHONIC PULMONARY TRANSMITT
K812849 · BTY
Pharmaquest Corp.
Anesthesiology · 55d
Cleared Dec 03, 1981
PTT-200 PULMONARY RECEIVER/MICROPROCES
K812850 · BTY
Pharmaquest Corp.
Anesthesiology · 55d
Cleared Dec 03, 1981
SURGICAL MASK
K812992 · FXX
South Mountain Medical
General Hospital · 38d
Cleared Dec 03, 1981
FILTER FLOW MASK CAT. #300
K812996 · FXX
Eldredge Mfg. Co.
General Hospital · 38d
Cleared Dec 03, 1981
FILTER FLOW MASK CAT. #350
K812997 · FXX
Eldredge Mfg. Co.
General Hospital · 38d
Cleared Dec 03, 1981
WA1000
K813024 · GEH
Wallach Surgical Devices, Inc.
General & Plastic Surgery · 36d
Cleared Dec 03, 1981
PORTABLE OXYGEN GENERATOR
K813058 · CAW
Respiratory Marketing, Inc.
Anesthesiology · 34d
Cleared Dec 03, 1981
MOBIL-AID AUTOMATIC EXPOSURE CONTROL
K813128 · IZL
Advanced Instrument Development, Inc.
Radiology · 28d
Cleared Dec 03, 1981
PLEXUFIX BRACHIAL PLEXUS ANESTH. NEEDLE
K813165 · BSP
Burron Medical Products, Inc.
Anesthesiology · 23d
Cleared Dec 03, 1981
LIQUIZYME GLUCOSE REAGENT
K813168 · CGA
American Research Products Co.
Chemistry · 17d
Cleared Dec 03, 1981
CELESTIN PULSION ESOPHOGEAL PROSTHESIS
K813169 · KNT
Inmed Corp.
Gastroenterology & Urology · 21d
Cleared Dec 03, 1981
PHENYLALANINE UV KINETIC TEST KIT
K813171 · JNB
Biochemicals, Inc.
Chemistry · 17d
Cleared Dec 03, 1981
PERICAN, EPIDURAL CANNULA
K813179 · BSP
Burron Medical Products, Inc.
Anesthesiology · 21d
Cleared Dec 03, 1981
PERFIX SET FOR EPIDURAL ANESTHESIA W/TUO
K813186 · CAZ
Burron Medical Products, Inc.
Anesthesiology · 17d