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
144001–144024 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 06, 1986
NON-KOR WINGED INFUSION SETS
K861406 · FMI
Creative Care Systems, Inc.
General Hospital · 21d
Cleared May 06, 1986
VEOLAR VENTILATOR
K861432 · CBK
Hamilton Medical, Inc.
Anesthesiology · 20d
Cleared May 06, 1986
CHURCHILL FEMALE LUER LOCK CAP
K861439 · FPA
Churchill Corp.
General Hospital · 19d
Cleared May 06, 1986
S1 VAGINAL PACKING
K861443 · EFQ
Surgical Specialties, Inc.
General & Plastic Surgery · 19d
Cleared May 06, 1986
S1 NASAL PACKING
K861444 · EFQ
Surgical Specialties, Inc.
General & Plastic Surgery · 19d
Cleared May 06, 1986
S1 CAVITY PACKING
K861445 · EFQ
Surgical Specialties, Inc.
General & Plastic Surgery · 19d
Cleared May 06, 1986
S1 ORAL PACKING
K861446 · EFQ
Surgical Specialties, Inc.
General & Plastic Surgery · 19d
Cleared May 06, 1986
STAGNONE SWIVEL-JOINT NEEDLE
K861453
Radtech, Inc.
General & Plastic Surgery · 18d
Cleared May 06, 1986
END TIDAL CO2 TUBE
K861454 · BTR
Sheridan Catheter Corp.
Anesthesiology · 18d
Cleared May 06, 1986
SHILEY SLEEP APNEA CUFFLESS FENESTRATED TRACH TUBE
K861461 · BTR
Shiley, Inc.
Anesthesiology · 15d
Cleared May 06, 1986
SHILEY SLEEP APNEA CUFFLESS TRACHEOSTOMY TUBE
K861462 · BTR
Shiley, Inc.
Anesthesiology · 15d
Cleared May 06, 1986
SHILEY SLEEP APNEA LOW PRESSURE CUFFED TRACH TUBE
K861463 · BTR
Shiley, Inc.
Anesthesiology · 15d
Cleared May 06, 1986
MODEL 63-654 THERMOMETER, ELECTRONICS, CLINICAL
K861473 · FLL
Radio Shack Div. Tandy Corp.
General Hospital · 14d
Cleared May 06, 1986
CHARCOAL AGAR BASE
K861480 · JSG
Gibco Laboratories Life Technologies,...
Microbiology · 14d
Cleared May 06, 1986
COMPANION 2800 VOLUME VENTILATOR REMOTE ALARM
K861488 · CBK
Puritan Bennett Corp.
Anesthesiology · 27d
Cleared May 06, 1986
PERMACLEAR SOLUTION CAT. NO. 4950
K861490 · KEM
Helena Laboratories
Pathology · 14d
Cleared May 06, 1986
DISPOSABLE SURG KITS/GOWNS/GUARDS/COVERS/MASKS
K861525 · FSM
D & D Products, Inc.
General & Plastic Surgery · 18d
Cleared May 05, 1986
STETHOSCOPE ELECTRONIC STETHOSCOPE SPHYGMOMANOMETE
K854356 · DQD
Fontaine Industries, Inc.
Cardiovascular · 188d
Cleared May 05, 1986
MODEL 500A VASCULAR SPECTRUM ANALYZER W/CW DOPPLER
K860435 · DPT
Multigon Industries, Inc.
Cardiovascular · 90d
Cleared May 05, 1986
VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM
K860465 · CIT
Abbott Laboratories
Chemistry · 88d
Cleared May 05, 1986
MINI-CHEM ANALYZER
K860987 · JJQ
Ocean Scientific, Inc.
Chemistry · 49d
Cleared May 05, 1986
CORDIS CATH SHEATH INTRODUC/MID-LENGTH SHEATH SYST
K861082 · DYB
Cordis Corp.
Cardiovascular · 45d
Cleared May 05, 1986
MODEL K110SX CENTRIFUGE
K861146 · JQC
Jouan S.A.
Chemistry · 40d
Cleared May 05, 1986
PHARMASEAL DUAL LUMEN CATHETER
K861165 · DQY
American Pharmaseal Div. Ahsc
Cardiovascular · 38d