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
127801–127824 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 29, 1989
HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015
K896643 · CFL
Medix Biotech, Inc.
Chemistry · 35d
Cleared Dec 29, 1989
TINY HALOGEN EXAM LIGHT
K896962 · KZF
Jedmed Instrument Co.
General Hospital · 14d
Cleared Dec 28, 1989
MULTILUMEN CENTRAL VENOUS CATHETER
K885221 · DQO
Bd Becton Dickinson Vacutainer...
Cardiovascular · 373d
Cleared Dec 28, 1989
GRASPING FORCEPS
K896058 · KOA
Annex Medical, Inc.
Gastroenterology & Urology · 71d
Cleared Dec 27, 1989
LATEX EXAMINATION GLOVES
K893461 · LYY
Zhum Heng Development , Ltd.
General Hospital · 238d
Cleared Dec 27, 1989
ACC.U.DIAL
K894423 · JJQ
Exocell, Inc.
Chemistry · 163d
Cleared Dec 27, 1989
E-Z-EM VACUUM ASPIRATION SYRINGE
K895012 · GAA
E-Z-Em, Inc.
General & Plastic Surgery · 141d
Cleared Dec 27, 1989
CLINISTAT HDL CHOLESTEROL REAGENT TEST
K895139 · LBS
Heraeus Kulzer, Inc.
Chemistry · 133d
Cleared Dec 27, 1989
CHEMO-SPIKE RECONSTITUTION DEVICE
K895290 · FPA
The Medi-Dose Group
General Hospital · 124d
Cleared Dec 27, 1989
IV DISPESNSING SPIKE
K895291 · FPA
The Medi-Dose Group
General Hospital · 124d
Cleared Dec 27, 1989
AMBULATORY INFUSION PUMP
K895426 · FRN
Bionica, Inc.
General Hospital · 113d
Cleared Dec 27, 1989
AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE
K895465 · JIH
Baxter Healthcare Corp
Chemistry · 107d
Cleared Dec 27, 1989
CAVITY DRAINAGE CATHETERIZATION SET, CS-01600
K895516 · GBX
Arrow Intl., Inc.
General & Plastic Surgery · 106d
Cleared Dec 27, 1989
LIFEPORT VASCULAR ACCESS PORT
K895689 · LJT
Strato Medical Corp.
General Hospital · 96d
Cleared Dec 27, 1989
MIKRO-LAVAGE-1
K895755 · GBX
Mikro-Tek Laboratories
General & Plastic Surgery · 92d
Cleared Dec 27, 1989
MIKRO-AQUAPURATOR
K895756 · GBX
Mikro-Tek Laboratories
General & Plastic Surgery · 92d
Cleared Dec 27, 1989
NON CONSTRAINED TOTAL SHOULDER SYSTEM
K895802 · KWT
Orthopaedic Medical Group, Inc.
Orthopedic · 90d
Cleared Dec 27, 1989
SERENE WRAP
K895865 · EFQ
Byron Medical
General & Plastic Surgery · 86d
Cleared Dec 27, 1989
BECKMAN MA MICROALBUMIN REAGENT KIT
K895883 · JIQ
Beckman Instruments, Inc.
Chemistry · 83d
Cleared Dec 27, 1989
BANDAGE REMOVAL STRIP
K895884 · KGX
Kut-Guard, Inc.
General & Plastic Surgery · 83d
Cleared Dec 27, 1989
NORMAL AND ABNORMAL CONTROL SERA
K895943 · JJY
Sclavo, Inc.
Chemistry · 77d
Cleared Dec 27, 1989
LATEX EXAMINATION GLOVES
K896003 · LYY
Jiea Chao Ent. Co., Ltd.
General Hospital · 75d
Cleared Dec 27, 1989
DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095
K896006 · KOC
Baxter Healthcare Corp
Gastroenterology & Urology · 75d
Cleared Dec 27, 1989
MODEL 6500 MERCURY ARC LIGHT SOURCE
K896008 · GCP
Medical Dynamics, Inc.
Gastroenterology & Urology · 75d