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
142393–142416 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 19, 1986
ROTARY MICROTOME
K863548 · IDO
Surgipath Medical Industries, Inc.
Pathology · 7d
Cleared Sep 18, 1986
MICROALBUMINURIA ASSAY
K862671 · DCF
Orion Corp.
Immunology · 66d
Cleared Sep 18, 1986
EMERSON MODEL 3HV COMPACT VENTILATOR
K862712 · CBK
J. H. Emerson Co.
Anesthesiology · 64d
Cleared Sep 18, 1986
POLYHESIVE R ELECTRODES/TENS MUSCLE STIM ELEC THER
K863035 · GXY
Valleylab, Inc.
Neurology · 38d
Cleared Sep 18, 1986
BYRON SILICONE CHIN IMPLANTS
K863397 · FWP
Byron Medical
General & Plastic Surgery · 15d
Cleared Sep 18, 1986
OXYGEN CANNULA EAR WRAP (STYLE A)
K863431 · CAT
Salter Labs
Anesthesiology · 14d
Cleared Sep 18, 1986
OXYGEN CANNULA EAR WRAP (STYLE B)
K863432 · CAT
Salter Labs
Anesthesiology · 14d
Cleared Sep 18, 1986
URESIL CLOSED DRAINAGE RESERVOIR
K863505 · GCY
Uresil Corp.
General & Plastic Surgery · 9d
Cleared Sep 18, 1986
CPU GRAPH
K863546 · CBK
Ohmeda Medical
Anesthesiology · 6d
Cleared Sep 17, 1986
40-HZ AUDITORY EVOKED RESPONSE TEST
K862361 · GWJ
Cadwell Laboratories, Inc.
Neurology · 86d
Cleared Sep 17, 1986
INSERT EARPHONES
K862363 · GWJ
Cadwell Laboratories, Inc.
Neurology · 86d
Cleared Sep 17, 1986
RESISTANT 6 MIC PANEL
K862978 · JWY
Pasco Laboratories, Inc.
Microbiology · 41d
Cleared Sep 17, 1986
CARDIOFAX ECG-6551 (ELECTROCARDIOGRPH)
K863116 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 34d
Cleared Sep 17, 1986
3M CORNEAL SYSTEM (CORNEAL PRESERVATION MEDIUM)
K863129 · LYX
3M Company
Ophthalmic · 33d
Cleared Sep 17, 1986
CHOLINESTERASE (BTC) REAGENT
K863203 · DIH
Sigma Diagnostics, Inc.
Chemistry · 29d
Cleared Sep 17, 1986
ALBUMIN (BCP)
K863226 · CJW
Sigma Diagnostics, Inc.
Chemistry · 27d
Cleared Sep 17, 1986
TOTAL BILIRUBIN PROCEDURE
K863262 · CIG
Data Medical Associates, Inc.
Chemistry · 23d
Cleared Sep 17, 1986
PRECIMAT (R) IGA, G, M
K863352 · CZP
Boehringer Mannheim Corp.
Immunology · 19d
Cleared Sep 17, 1986
PHADIOTOP (TM) RIA/PHADIOTOP (TM) EIA
K863355 · DHB
Pharmacia, Inc.
Immunology · 19d
Cleared Sep 17, 1986
BYRON NASAL SEPTAL BUTTON
K863398 · FZE
Byron Medical
General & Plastic Surgery · 14d
Cleared Sep 17, 1986
BYRON DORSAL COLUMELLA IMPLANT
K863399 · FZE
Byron Medical
General & Plastic Surgery · 14d
Cleared Sep 17, 1986
BYRON EXTENDED MALAR AND BYRON CONTOURED MALAR
K863400 · LZK
Byron Medical
General & Plastic Surgery · 14d
Cleared Sep 17, 1986
MICROBIPOLATOR
K863414 · GEI
Treace Medical, Inc.
General & Plastic Surgery · 14d
Cleared Sep 17, 1986
BYRON BIVALVE NASAL SPLINTS
K863430 · FZE
Byron Medical
General & Plastic Surgery · 13d