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
128089–128112 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 1989
URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS
K895821 · KNK
Catachem, Inc.
Chemistry · 67d
Cleared Dec 05, 1989
SYNCHRON CX SYSTEMS (LAP) REAGENT KIT
K895850 · JGG
Beckman Instruments, Inc.
Chemistry · 63d
Cleared Dec 05, 1989
NON-STERILE LATEX EXAMINATION GLOVES
K896220 · LYY
Allstar Sdn. Bhd.
General Hospital · 36d
Cleared Dec 05, 1989
IMMUNODOT AUTOIMMUNE SCREENING PANEL 1
K896347 · LJM
General Biometrics, Inc.
Immunology · 32d
Cleared Dec 04, 1989
POLYETHER-RETARDER
K892412 · ELW
Espe GmbH (Us)
Dental · 238d
Cleared Dec 04, 1989
KULZER GLAS-IONOMER CEMENT
K892453 · EMA
Kulzer, Inc.
Dental · 238d
Cleared Dec 04, 1989
AQUATREX UNDERWATER TREADMILL SYSTEM
K895104 · IOL
Edmonds Medical Systems
Physical Medicine · 111d
Cleared Dec 04, 1989
SARNS INGANT MEMBRANE OXYGENATOR
K895393 · DTZ
3M Company
Cardiovascular · 90d
Cleared Dec 04, 1989
NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM
K895401 · EBF
Rocky Mountain Orthodontics, Inc.
Dental · 88d
Cleared Dec 04, 1989
ALCON FOLDING FORCEPS
K895434 · HNR
Alcon Laboratories
Ophthalmic · 87d
Cleared Dec 04, 1989
SITE 810E PHOTOCOAGULATOR AND ACCESSORIES
K895663 · GEX
Site Microsurgical Systems, Inc.
General & Plastic Surgery · 75d
Cleared Dec 04, 1989
BREVET FLOSS PICK (AUTOCLAVE STERILIZER)
K895958 · EKJ
Brevet, Inc.
Dental · 54d
Cleared Dec 04, 1989
GNATHOMAT ARTICULATOR
K896131 · EJP
Ivoclar North America, Inc.
Dental · 42d
Cleared Dec 04, 1989
STERILE SURGICAL DRAPES AND SHEETS
K896367 · KKX
Clinitech, Inc.
General Hospital · 28d
Cleared Dec 04, 1989
MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT
K896585 · DBF
Medix Biotech, Inc.
Immunology · 13d
Cleared Dec 04, 1989
CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY
K896592 · DHB
Ciba Corning Diagnostics Corp.
Immunology · 13d
Cleared Dec 01, 1989
OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE
K883400 · KPE
Abbott Laboratories
General Hospital · 476d
Cleared Dec 01, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891493 · LYY
Cinderella Ent. Co., Ltd.
General Hospital · 260d
Cleared Dec 01, 1989
PATIENT EXAMINATION GLOVES
K892279 · LYY
Aek Rubber Product Sdn. Bhd.
General Hospital · 241d
Cleared Dec 01, 1989
STETH-SHIELD(TM)
K892890 · DQD
North East Technology
Cardiovascular · 225d
Cleared Dec 01, 1989
3-RING HANDLE, GRASP FORCEPS, LOOP RETRIE., BASKET
K894986 · OCZ
North American Sterilization &...
Gastroenterology & Urology · 115d
Cleared Dec 01, 1989
S.A.F. ACETABULAR CUP
K895157 · KWA
Synergy Orthopaedics Intl., Inc.
Orthopedic · 113d
Cleared Dec 01, 1989
BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST
K895362 · JTT
Bd Becton Dickinson Vacutainer...
Microbiology · 94d
Cleared Dec 01, 1989
OSBON PERSONAL LUBRICANT
K895406 · KMJ
Osbon Medical Systems, Ltd.
General Hospital · 86d