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
135625–135648 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 21, 1988
SPIROCHETES HISTOLOGY CONTROL SLIDES
K881109 · LJG
Sigma Diagnostics, Inc.
Microbiology · 37d
Cleared Apr 21, 1988
FUNGI HISTOLOGY CONTROL SLIDES
K881112 · LJG
Sigma Diagnostics, Inc.
Microbiology · 37d
Cleared Apr 21, 1988
QM300 CALIBRATOR D PACK
K881127 · DCF
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 36d
Cleared Apr 21, 1988
CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO.
K881138 · JMG
Baxter Healthcare Corp
Immunology · 36d
Cleared Apr 21, 1988
CELL-DYN RAPID-LYSE AND HEMOGLOBLIN
K881242 · GJZ
Abbott Diagnostics
Hematology · 36d
Cleared Apr 21, 1988
ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW
K881253 · ELC
Dentalez Group
Dental · 29d
Cleared Apr 21, 1988
NON CORING INFUSION SET
K881256 · LJT
Taris Corp.
General Hospital · 29d
Cleared Apr 21, 1988
ASSIST-A-LIFT
K881298 · INO
Action Engineering, Inc.
Physical Medicine · 24d
Cleared Apr 21, 1988
ORTHODONTIC NITINOL SPRINGS
K881331 · EJW
Flexmedics
Dental · 23d
Cleared Apr 21, 1988
OLYMPIA ALLOY
K881333 · EJJ
J.F. Jelenko & Co., Inc.
Dental · 23d
Cleared Apr 21, 1988
NOVA LITE(TM) ANA PLUS
K881339 · LLL
Inova Diagnostics, Inc.
Immunology · 23d
Cleared Apr 21, 1988
KIN-COM JR
K881388 · LBB
Chattanooga Group, Inc.
Neurology · 17d
Cleared Apr 21, 1988
THE ADVENTURER
K881410 · IOR
Westport Mobility Products, Inc.
Physical Medicine · 17d
Cleared Apr 21, 1988
ELECTRO-CAUTERY SUCTION TUBE
K881413 · GEI
Alto Development Corp.
General & Plastic Surgery · 17d
Cleared Apr 21, 1988
HEART CHECK APOLIPOPROTEIN-B
K881433 · MSJ
Northwest Biotech
Immunology · 16d
Cleared Apr 21, 1988
HEART CHECK APOLIPOPROTEIN A-1
K881434 · MSJ
Northwest Biotech
Immunology · 16d
Cleared Apr 21, 1988
FOLDING WHEELCHAIR
K881452 · IOR
Health Care Innovations, Inc.
Physical Medicine · 15d
Cleared Apr 21, 1988
KODAK SURECELL STREP A TEST KIT
K881457 · GTZ
Eastman Kodak Company
Microbiology · 15d
Cleared Apr 21, 1988
CRYOBIOLOGICAL FREEZER
K881465 · KSP
Cryodyne Technologies, Inc.
Pathology · 15d
Cleared Apr 21, 1988
MODIFIED PARACON(TM) CONCENTRATION KIT
K881649 · LKS
Para Scientific Co.
Microbiology · 6d
Cleared Apr 21, 1988
TISSUE SECTION ADHESIVE
K881659 · IFZ
Surgipath Medical Industries, Inc.
Pathology · 6d
Cleared Apr 21, 1988
IMMULON 4 FLAT BOTTOM PLATES & REMOVAWELL STRIPS
K881675 · JZQ
Dynatech Laboratories, Inc.
Immunology · 3d
Cleared Apr 19, 1988
CSPI SPECIMEN TRAP (NON-STERILE)
K870874 · GCX
Custom Surgical Products, Inc.
General Hospital · 413d
Cleared Apr 19, 1988
SS-1000 POLYGRAPH
K872520 · DQA
Meramed Corp.
Anesthesiology · 299d