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
170977–171000 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 1978
HMA URIC ACID TEST
K781004 · KNK
Hycel, Inc.
Chemistry · 41d
Cleared Jul 27, 1978
ANALYZER, SERUM IRON & TOTAL IRON BINDIN
K781009 · JMD
Environmental Sciences Assoc., Inc.
Chemistry · 38d
Cleared Jul 27, 1978
MERCURY/HYDRIDE ATOMIC ABSORPTION ACCESS
K781010 · DPH
The Perkin-Elmer Corp.
Toxicology · 41d
Cleared Jul 27, 1978
RIA TEST KIT SYS. DAMON KIQUISOL FREE
K781012 · CEC
Damon Corp.
Hematology · 41d
Cleared Jul 27, 1978
(AST) OR (ALT) UV DETERM. PHY. PHOS.
K781020 · CIT
The Dow Chemical Co.
Chemistry · 42d
Cleared Jul 27, 1978
LAMBDA SERUM (FREE) ANTI-HUMAN
K781025 · DEH
Icl Scientific
Immunology · 38d
Cleared Jul 27, 1978
KAPPA SERUM (FREE) ANTI-HUMAN
K781027 · DFH
Icl Scientific
Immunology · 38d
Cleared Jul 27, 1978
KAPPA SERUM (FREE & BOUND) ANTI-HUMAN
K781028 · DFH
Icl Scientific
Immunology · 38d
Cleared Jul 27, 1978
AEROPLAST DRESSING
K781031 · KMF
Parke-Davis Co.
General & Plastic Surgery · 38d
Cleared Jul 27, 1978
PROLITH 23S PACEMAKER
K781042 · DXY
Edwards Pacemaker Systems
Cardiovascular · 37d
Cleared Jul 27, 1978
A-33 DENTAL ALLOY
K781045 · EJT
Howmedica Corp.
Dental · 36d
Cleared Jul 27, 1978
LIFELINE AMBULATORY
K781054 · DPS
Imc
Cardiovascular · 36d
Cleared Jul 27, 1978
CONTROL, HEMATOLOGY, CH-60
K781077 · JPK
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 29d
Cleared Jul 27, 1978
MONITOR KITS, BLOOD LEVEL
K781145 · DTW
3M Health Care, Sarns
Cardiovascular · 17d
Cleared Jul 27, 1978
RIA TSH IN HUMAN SERUM OR PLASMA
K781150 · JLW
Diagnostic Corp. of America
Immunology · 17d
Cleared Jul 27, 1978
CHOLESTEROL & HDL CHOL. PROCEDURE
K781165
Data Medical Associates, Inc.
Chemistry · 15d
Cleared Jul 27, 1978
WRENCH, GEXAGON, DRIVER
K781179 · DTF
Telectronics, Inc.
Cardiovascular · 13d
Cleared Jul 27, 1978
COMPRESSOR, AIR, MINI-SILENT
K781213 · BTI
The John Bunn Co.
Anesthesiology · 17d
Cleared Jul 27, 1978
ANEMOMETER, NASAL, EXETER
K781218 · ETL
Medika Corp.
Ear, Nose, Throat · 10d
Cleared Jul 27, 1978
ANTI-HUMAN LAMBDA SERUM
K781220 · DEH
Icl Scientific
Immunology · 10d
Cleared Jul 27, 1978
OXYGENATOR, BLOOD, INFANT/PEDIATRIC
K781223 · DTZ
Shiley, Inc.
Cardiovascular · 10d
Cleared Jul 26, 1978
LEAD, PACING, ATRIAL, ENDOCARDIAL, TINED
K780621 · DTB
Medtronic Vascular
Cardiovascular · 103d
Cleared Jul 19, 1978
SURGICAL LASER
K780585 · GEX
Laser Industries , Ltd.
General & Plastic Surgery · 99d
Cleared Jul 19, 1978
STERILE INFUSION SET TYPE S
K780655 · FPA
Suru Chemicals & Pharmaceuticals, Ltd.
General Hospital · 90d