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
171529–171552 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 1978
PINWHEEL
K780422 · GWY
Projects IN Health
Neurology · 18d
Cleared Apr 03, 1978
NEBULIZER, DISP, 2D0815
K780119 · CAF
Travenol Laboratories, S.A.
Anesthesiology · 70d
Cleared Apr 03, 1978
URINE SAMPLE KIT
K780336 · KDD
American Hospital Supply Corp.
General & Plastic Surgery · 34d
Cleared Mar 31, 1978
DIALYZING FLUIDE DELIVERY SYSTEM
K780081 · FKQ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 74d
Cleared Mar 31, 1978
IMAGER, BODY SECTION, RADIONUCLIDE
K780395 · IYW
Union Carbide Corp.
Radiology · 18d
Cleared Mar 30, 1978
PLATELET ROTATOR
K780189 · KSQ
Travenol Laboratories, S.A.
Hematology · 52d
Cleared Mar 30, 1978
SOLUBLE COLLAGEN
K780285 · JOZ
General Diagnostics
Hematology · 37d
Cleared Mar 30, 1978
AUTO ISO-FILTER COLLECTION TUBE CAP
K780303 · GJE
Bd Becton Dickinson Vacutainer...
Chemistry · 35d
Cleared Mar 30, 1978
MANIFOLD KIT
K780364 · CAN
Spica, Inc.
Anesthesiology · 24d
Cleared Mar 30, 1978
OXYGEN/NITROUS OXIDE OUTLET
K780365 · CAM
Spica, Inc.
Anesthesiology · 24d
Cleared Mar 30, 1978
STIKSEP-T4 RIA KIT
K780423 · CDX
Nuclear Diagnostics, Inc.
Toxicology · 14d
Cleared Mar 30, 1978
ROCHE TSH RIA
K780428 · JLW
Hoffmann-La Roche, Inc.
Chemistry · 13d
Cleared Mar 30, 1978
TRACOR RA 410 AUDIOMETER
K780450 · EWO
Tracor Instruments, Inc.
Ear, Nose, Throat · 10d
Cleared Mar 30, 1978
CLEARTONE MODEL-1 & 2 HEARING AIDS
K780459 · ESD
Cleartone Custom Hearing Instruments
Ear, Nose, Throat · 7d
Cleared Mar 30, 1978
AUDIOMETER CALIBRATOR MODEL RA 310
K780474 · EWA
Tracor Instruments, Inc.
Ear, Nose, Throat · 6d
Cleared Mar 28, 1978
I.V. START KIT
K780222 · FRO
Marion Laboratories, Inc.
General & Plastic Surgery · 47d
Cleared Mar 28, 1978
REAGENT SYSTEM, ARIA II T3 UPTAKE
K780253 · KHQ
Bd Becton Dickinson Vacutainer...
Chemistry · 42d
Cleared Mar 28, 1978
HDL CHOLESTEROL METHOD
K780256 · JHO
Helena Laboratories
Chemistry · 43d
Cleared Mar 28, 1978
G WRAP
K780294 · FRG
Cel-Fibe
General Hospital · 35d
Cleared Mar 28, 1978
ADHESIVE, BRACKET AND CONDITIONER RESIN
K780334 · DYH
Rocky Mountain Orthodontics, Inc.
Dental · 28d
Cleared Mar 28, 1978
ECG MONITORING SYSTEM,
K780404 · DRT
Quinton, Inc.
Cardiovascular · 15d
Cleared Mar 27, 1978
IN VITRO THEOPHYLLINE RIA TEST
K772017 · KLS
Clinical Assays, Inc.
Immunology · 152d
Cleared Mar 27, 1978
CELL-CHEX
K780140 · JPK
Streck Laboratories, Inc.
Hematology · 60d
Cleared Mar 27, 1978
DIGAPHOT PHOTOTHERAPY METER MODEL PT 145
K780162 · FTA
Cavitron Corp.
General & Plastic Surgery · 55d