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
162841–162864 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 1981
BLADE GAUGE
K812011 · HOE
Koi, Inc.
Ophthalmic · 11d
Cleared Jul 28, 1981
FLUORESCENT ANTIBODY CONJUGATE FOR GP.A
K812013 · GTX
Springwood Microbiologicals
Microbiology · 11d
Cleared Jul 28, 1981
MONOJECT STERILE M506 6CC SYRINGES
K812023 · FMF
Sherwood Medical Co.
General Hospital · 8d
Cleared Jul 28, 1981
IMED ACCUSET CASSETTE
K812035 · FRN
Imed Corp.
General Hospital · 8d
Cleared Jul 28, 1981
TEMPERATURE MONITOR 130/131/133
K812037 · FLL
Medix Medical Electronics (U.S.A.), Inc.
General Hospital · 7d
Cleared Jul 27, 1981
SEMI-CONSTRAINT KEE JOINT HINGE PROSTH
K811105 · KRO
Allo Pro Corp.
Orthopedic · 95d
Cleared Jul 27, 1981
CHEMSTRIP L
K811189 · GHD
Biodynamics Corp.
Hematology · 89d
Cleared Jul 27, 1981
ARACHIDONIC ACID
K811290 · JBX
Bio/Data Corp.
Chemistry · 77d
Cleared Jul 27, 1981
COMMAND P5(UNIPOLAR PULSE GENERATOR)
K811401
Cardiac Pacemakers, Inc.
Cardiovascular · 69d
Cleared Jul 27, 1981
COMMAND P5(BIPOLAR PULSE GENERATOR)
K811402 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 70d
Cleared Jul 27, 1981
CUSTOM IN-THE-EAR HEARING AID
K811719 · ESD
Hearing Health Group, Inc.
Ear, Nose, Throat · 39d
Cleared Jul 27, 1981
ACCRA-LAB GRAM STAIN SET 55760
K811780 · JTS
Accra Laboratories, Inc.
Pathology · 34d
Cleared Jul 27, 1981
SIGMA PROCEDURE #890
K811784 · GJS
Sigma Chemical Co.
Toxicology · 34d
Cleared Jul 27, 1981
PO-200 BLOOD OXYGEN MONITOR
K811836 · KLK
Sumitomo Electric Industries, Inc.
Anesthesiology · 27d
Cleared Jul 27, 1981
SKIN STAPLE EXTRACTOR
K811887 · KBC
Sierra Laboratories, Inc.
Ear, Nose, Throat · 26d
Cleared Jul 27, 1981
ORTHO SICKLE CELL CONTROLS
K811894 · GKA
Ortho Diagnostic Systems, Inc.
Hematology · 26d
Cleared Jul 27, 1981
NEOCEPT
K811941 · JHJ
Organon, Inc.
Chemistry · 21d
Cleared Jul 27, 1981
COMBO-FER IRON DIAGNOSTIC
K811954 · JQG
Immuno Assay Corp.
Chemistry · 19d
Cleared Jul 27, 1981
BOUNDARY REINFORCED OR GOWN
K811958 · FYA
The Buckeye Cellulose Corp.
General Hospital · 18d
Cleared Jul 27, 1981
MODEL 480 VARIABLE WAVELENGTH ULTRA VIOL
K811975 · JJQ
Waters Assoc., Inc.
Radiology · 14d
Cleared Jul 27, 1981
OXY-QUIK MARK IV OXYGEN INHALATOR
K811987 · DRM
Oxequip Health Ind.
Cardiovascular · 14d
Cleared Jul 27, 1981
TRACH CLEANING TRAY
K811990 · FRL
Associated Medical Products Co.
General Hospital · 14d
Cleared Jul 27, 1981
RADIOIMMUNOASSAY LUTEINIZING HORMONE
K811994 · CEP
Endocrine-Metabolic Center
Chemistry · 13d
Cleared Jul 27, 1981
A-GENT THEOPHYLLINE
K812003 · KLS
Abbott Laboratories
Chemistry · 13d