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
154921–154944 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 1983
EARLY PREGNANCY DETECTION TEST KIT
K833466 · LCX
Quidel Corp.
Chemistry · 50d
Cleared Nov 25, 1983
HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK
K833665 · HYF
J.S. Medical Assoc.
Hematology · 38d
Cleared Nov 25, 1983
QUICK STAIN WRIGHT'S GIEMSA W/BUFF
K833677 · HYF
J.S. Medical Assoc.
Hematology · 38d
Cleared Nov 25, 1983
HEMATOLOGY WRIGHT'S STAIN PACK
K833678 · IAF
J.S. Medical Assoc.
Hematology · 38d
Cleared Nov 22, 1983
DONALDSON VENT TUBE
K823910 · ETD
Treace Medical, Inc.
Ear, Nose, Throat · 329d
Cleared Nov 22, 1983
OXYGEN CONCENTRATOR RESPIRATORY SUPPOR
K831819 · CAW
Eagle Medical Equipment Co.
Anesthesiology · 169d
Cleared Nov 22, 1983
GASLINE FILTER, #EC-GLF SERIES
K832935 · CAH
Gish Biomedical, Inc.
General Hospital · 84d
Cleared Nov 22, 1983
STAODYN EMS/PLUS
K832988 · IPF
Staodynamics, Inc.
Physical Medicine · 82d
Cleared Nov 22, 1983
TSH RIA
K833910 · ETD
Syncor Intl. Corp.
Chemistry · 8d
Cleared Nov 21, 1983
CAPNOMETER W/NEW AIRWAY ADAPTER 47210A
K831447 · CCK
Hewlett-Packard Co.
Anesthesiology · 200d
Cleared Nov 21, 1983
POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE
K831984 · DGO
Diagnostic Reagent Tech.
Microbiology · 154d
Cleared Nov 21, 1983
PERSONAL AMPLIFIER
K832168 · ESD
Electone, Inc.
Ear, Nose, Throat · 138d
Cleared Nov 21, 1983
POLYSTYRENE MICROTITER PLATE IMMUNO-
K832344 · DHB
Diagnostic Reagent Tech.
Immunology · 131d
Cleared Nov 21, 1983
OPTHALMIC ENDOSCOPE
K832405
Cilco, Inc.
Neurology · 123d
Cleared Nov 21, 1983
DIACROM *PLG
K832591 · DDX
Wellcome Diagnostics
Immunology · 111d
Cleared Nov 21, 1983
TOP VENULA I.V. CATHETER SET
K832624 · FOZ
Top Surgical Manufacturers Co.
General Hospital · 109d
Cleared Nov 21, 1983
INNOVATIVE HEARING CORP. #IHC 1000
K832633 · ESD
Innovative Hearing Corp.
Ear, Nose, Throat · 109d
Cleared Nov 21, 1983
ALPHA-I
K832642 · LHC
Johnson Flexgroup
General Hospital · 109d
Cleared Nov 21, 1983
COLOSCREEN V.P.I.
K832864 · KHE
Helena Laboratories
Immunology · 90d
Cleared Nov 21, 1983
TRAVASPORE BIOLOGICAL INDICATOR
K832922 · FRC
Travenol Laboratories, S.A.
General Hospital · 89d
Cleared Nov 21, 1983
C-FLEX MEDICAL GRADE TUBING
K833076 · FPK
Concept, Inc.
General Hospital · 73d
Cleared Nov 21, 1983
DESERET SUBCLAVIAN JUGULAR CATH-SET
K833091 · FOZ
Warner-Lambert Co.
General Hospital · 70d
Cleared Nov 21, 1983
DESERET ANGIO-GUIDE LARGE VEIN CATH.
K833092 · FOZ
Warner-Lambert Co.
General Hospital · 70d
Cleared Nov 21, 1983
REPORTING INTEGRATOR 3392A
K833113 · LDM
Hewlett-Packard Co.
Toxicology · 69d