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
165673–165696 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 1980
BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY
K801750 · CIX
Beckman Instruments, Inc.
Chemistry · 50d
Cleared Sep 16, 1980
RAMI ULTRAVIOLET A BOOTH
K801751 · LEJ
Rami-Tan
Radiology · 50d
Cleared Sep 16, 1980
RAMI TAN ULTRAVIOLET B BOOTH
K801752 · LEJ
Rami-Tan
Radiology · 50d
Cleared Sep 16, 1980
GLUCOSE REAGENT(UV-HEXOKINASE)
K801765 · CFR
Reagents Applications, Inc.
Chemistry · 50d
Cleared Sep 16, 1980
DIMENSION I REFRACTION SYSTEM
K801767 · HLM
Smr
Ophthalmic · 50d
Cleared Sep 16, 1980
BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.
K801795 · JGS
J.T. Baker Chemical Co.
Chemistry · 49d
Cleared Sep 16, 1980
WAKO HDL CHOLESTEROL TEST
K801834 · LBS
Wako Pure Chemical Industries, Ltd.
Chemistry · 46d
Cleared Sep 16, 1980
DISPOSABLE HYPODERMIC NEEDLES
K801839 · FMI
Martin'S Maine Exchange
General Hospital · 46d
Cleared Sep 16, 1980
T3(125) RADIOIMMUNOASSAY KIT
K801843 · CDP
Technia Diagnostics , Ltd.
Chemistry · 46d
Cleared Sep 16, 1980
LACTI-QUANT
K801849 · CFT
Nuclear Medical Laboratories, Inc.
Chemistry · 43d
Cleared Sep 16, 1980
CHARLES PNEUMATIC INTRAOCULAR SCISSORS
K801850 · HQE
Cooper Medical Devices Corp.
Ophthalmic · 43d
Cleared Sep 16, 1980
CENTRIFICHEM PIPETTOR 1000
K801851 · JQW
Union Carbide Corp.
Chemistry · 43d
Cleared Sep 16, 1980
SPINAL FLUID CONTROL(HUMAN)
K801854 · JJX
Environmental Chemical Specialties
Chemistry · 43d
Cleared Sep 16, 1980
DATA-ZYME AST(GOT) PROCEDURE
K801856 · CIT
Data Medical Associates, Inc.
Chemistry · 43d
Cleared Sep 16, 1980
DATA-ZYME LAT(GPT) PROCEDURE
K801857 · CKA
Data Medical Associates, Inc.
Chemistry · 43d
Cleared Sep 16, 1980
PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A
K801866 · EQL
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 42d
Cleared Sep 16, 1980
STREP B POLYVALENT FLUORO-KIT
K801876 · GTX
Clinical Sciences, Inc.
Microbiology · 42d
Cleared Sep 16, 1980
SLIT LAMP ATTACHMENT
K801877 · HQB
Cavitron Corp.
Ophthalmic · 41d
Cleared Sep 16, 1980
NOVA 4 SODIUM/POTASSIUM/CHLORIDE/CARBON
K801882 · JGS
Nova Biomedical Corp.
Chemistry · 40d
Cleared Sep 16, 1980
WAKO TRIGLYCERIDE-G TEST
K801891 · CDT
Wako Pure Chemical Industries, Ltd.
Chemistry · 39d
Cleared Sep 16, 1980
CORNING 60 VOLT POWER SUPPLY
K801893 · JJN
Corning Medical & Scientific
Chemistry · 39d
Cleared Sep 16, 1980
BECKMAN ELECTROLYTE-2 SODIUM/POTASSIUM
K801896 · JGS
Beckman Instruments, Inc.
Chemistry · 39d
Cleared Sep 16, 1980
ALGESIOMETER
K801907 · GXB
Rowan Products, Inc.
Neurology · 36d
Cleared Sep 16, 1980
ARROW POSITIVE PLACEMENT CON/EPIDURAL AN
K801912 · CAZ
Arrow Intl., Inc.
Anesthesiology · 36d