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
163801–163824 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 1981
AMES TDA TOBRAMYCIN TEST
K810941 · LCR
Miles Laboratories, Inc.
Toxicology · 10d
Cleared Apr 17, 1981
AMES TDA GENTAMICIN TEST
K810942 · LCQ
Miles Laboratories, Inc.
Toxicology · 10d
Cleared Apr 17, 1981
AMES TDA THEOPHYLLINE TEST
K810943 · LER
Miles Laboratories, Inc.
Toxicology · 10d
Cleared Apr 17, 1981
RADIOIMMUNOASSAY THYROID STIM. HORM. KIT
K810948 · JLW
Endocrine-Metabolic Center
Chemistry · 10d
Cleared Apr 17, 1981
CORNING VITAMIN B12 FOLATE DEFIC. CONTR.
K810952 · JJY
Corning Medical & Scientific
Chemistry · 10d
Cleared Apr 17, 1981
MARCOVE HUMERAL ROD
K810956 · HSB
Hexcel Medical
Orthopedic · 10d
Cleared Apr 17, 1981
MARCOVE INTRAMEDULLARY ROD
K810957 · HSB
Hexcel Medical
Orthopedic · 10d
Cleared Apr 17, 1981
BIO SET TM SUBSTRATE CALIBRATORS
K810963 · JIS
Boehringer Mannheim Corp.
Chemistry · 9d
Cleared Apr 17, 1981
BIO SET TM PHOSPHOROUS CALIBRATOR
K810964 · JIX
Boehringer Mannheim Corp.
Chemistry · 9d
Cleared Apr 17, 1981
DATA-ZYME TRIGLYCERIDE
K810965 · CDT
Data Medical Associates, Inc.
Chemistry · 9d
Cleared Apr 16, 1981
PACE AID
K811028
Cardiac Resucitator Corp.
Cardiovascular
Cleared Apr 15, 1981
UTENSIL & PROCEDURE TRAYS
K810242 · FRL
American Hospital Supply Corp.
General Hospital · 77d
Cleared Apr 14, 1981
VAP 2001
K801181
Blendette Intl. , Ltd.
General Hospital · 333d
Cleared Apr 14, 1981
THROMBOPLASTIN
K810350 · GJS
Pacific Hemostasis
Immunology · 63d
Cleared Apr 14, 1981
SR-IVOSEAL
K810523 · ELW
J. Aderer, Inc.
Dental · 47d
Cleared Apr 14, 1981
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE
K810603 · DXY
Telectronics, Inc.
Cardiovascular · 39d
Cleared Apr 14, 1981
ELECTRODE/PACER SYSTEM ANALYZER PMA 400
K810604 · DTC
Telectronics, Inc.
Cardiovascular · 39d
Cleared Apr 14, 1981
SR-IVOSEAL(SOFT RELINING)
K810656
J. Aderer, Inc.
Dental · 47d
Cleared Apr 14, 1981
BRAUN TRAVEL
K810666 · JEQ
Gilette Medical Eval. Laboratory
Dental · 33d
Cleared Apr 14, 1981
SR-IVOLEN
K810686 · EBH
J. Aderer, Inc.
Dental · 32d
Cleared Apr 14, 1981
SR-IVOCAP
K810687 · EBI
J. Aderer, Inc.
Dental · 32d
Cleared Apr 14, 1981
EXMOOR AURAL GROMMET
K810701 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 29d
Cleared Apr 14, 1981
EXMOOR AURAL GROMMET AG/T2L
K810702 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 29d
Cleared Apr 14, 1981
EXMOOR AURAL GROMMET AG/T2
K810703 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 29d