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
155185–155208 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 28, 1983
FEELEY-GORMAN AGAR
K833301 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 36d
Cleared Oct 27, 1983
GUTTMAN INFUSION NEEDLE
K830568 · FMI
Cosmetic Sciences, Inc.
General Hospital · 247d
Cleared Oct 27, 1983
WLECTROCARDIOGRAPH ECG-7204
K831274 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 191d
Cleared Oct 27, 1983
CMV IGM TEST
K831711 · LKQ
Gull Laboratories, Inc.
Immunology · 153d
Cleared Oct 27, 1983
DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM
K831825 · KPJ
Hospitak, Inc.
General & Plastic Surgery · 142d
Cleared Oct 27, 1983
PACEMAKER PROGRAMMER #2032
K831859 · DXY
Vitatron Medical BV
Cardiovascular · 139d
Cleared Oct 27, 1983
GENERATOR, PULSE, PACEMAKER #532
K831860 · DXY
Vitatron Medical BV
Cardiovascular · 139d
Cleared Oct 27, 1983
SHARE INT'L TDM
K832067 · HCJ
Share Int'L
Neurology · 122d
Cleared Oct 27, 1983
COAT-A-COUNT FREE T3 RIA KIT
K832164 · CDP
Diagnostic Products Corp.
Chemistry · 114d
Cleared Oct 27, 1983
YBBOTT CMV TOTAL AB EIA
K832221 · LFZ
Abbott Laboratories
Microbiology · 111d
Cleared Oct 27, 1983
SLIMB SINGLE LIMB BREATHING CIRCUIT
K832453 · CAI
Respiratory Care, Inc.
Anesthesiology · 93d
Cleared Oct 27, 1983
CS-11
K832500 · EBE
Chema-Scutum, Inc.
Dental · 92d
Cleared Oct 27, 1983
SOLUTION ADMIN. LINE W/SPIKE
K832549 · FPA
Vascular Specialties, Inc.
General Hospital · 87d
Cleared Oct 27, 1983
ACCU-PREP PROGRAMMABLE AUTO-DILUTER
K832809 · JQW
Beckman Instruments, Inc.
Chemistry · 70d
Cleared Oct 27, 1983
ACA TOBRAMYCIN CALIBRATOR
K832982 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 55d
Cleared Oct 27, 1983
TOBRAMYCIN ANALYTICAL TEST PACK-ACA
K832985 · KLB
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 55d
Cleared Oct 27, 1983
CIN AGAR YERSINIA-SELECTIVE AGAR
K833010 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology · 51d
Cleared Oct 27, 1983
HCC-MYCOBACTERIA STAIN KIT
K833131 · LIB
Dr. C.V. Jacob
Microbiology · 44d
Cleared Oct 27, 1983
DISPOSBLADE LARYNGOSCOPE
K833133 · CCW
Geller & Bozeman
Anesthesiology · 44d
Cleared Oct 27, 1983
CLOSTRIDIUM DIFFICILE
K833136 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology · 43d
Cleared Oct 27, 1983
L-15-LEIBOVITZ W/L-GLUTAMINE-L4386
K833164 · KIT
Sigma Chemical Co.
Chemistry · 41d
Cleared Oct 27, 1983
HPR HOME PATIENT RENATRON
K833181 · LIF
Renal Systems, Inc.
Gastroenterology & Urology · 38d
Cleared Oct 27, 1983
APLICARE ALCOHOL PREP PAD
K833182 · LKB
Aplicare, Inc.
General Hospital · 38d
Cleared Oct 27, 1983
APLICARE THREE ALCOHOL SWABSTICKS
K833184 · LKB
Aplicare, Inc.
General Hospital · 38d