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
127489–127512 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 23, 1990
QS90 SMOOTH E ARTERIAL BLOOD SAMPLER
K896514 · GIM
Radiometer America, Inc.
Chemistry · 70d
Cleared Jan 23, 1990
PC/QCT QUANTITATIVE SOFTWARE
K896677 · KGI
The Institute For Radiological Image...
Radiology · 57d
Cleared Jan 23, 1990
MODEL 6000
K896789 · LNH
Medical Advances, Inc.
Radiology · 50d
Cleared Jan 23, 1990
NIIC LASER SYSTEM
K896988 · GEX
Niic U.S.A., Inc.
General & Plastic Surgery · 49d
Cleared Jan 23, 1990
LATEX PATIENT EXAMINATION GLOVES
K897139 · LYY
Kanam Latex Industries Pvt. , Ltd.
General Hospital · 27d
Cleared Jan 23, 1990
SURETEX LATEX EXAMINATION GLOVES
K900212 · LYY
Gulf Medical Technologies, Inc.
General Hospital · 6d
Cleared Jan 22, 1990
J.M. PATIENT EXAMINATION GLOVES
K891624 · LYY
Jann Maw (U.S.A.), Inc.
General Hospital · 308d
Cleared Jan 22, 1990
PATIENT EXAMINATION GLOVES
K893074 · LYY
Taba Gloves Pvt. , Ltd.
General Hospital · 284d
Cleared Jan 22, 1990
SURGEON'S GLOVES
K893522 · FGO
Thai Fuji Latex Co., Ltd.
Gastroenterology & Urology · 259d
Cleared Jan 22, 1990
MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR
K894030 · HFM
Healthdyne, Inc.
Obstetrics & Gynecology · 230d
Cleared Jan 22, 1990
PHARMACIA CAP SYSTEM RAST RIA & RAST FEIA
K894190 · DHB
Pharmacia, Inc.
Immunology · 220d
Cleared Jan 22, 1990
MESAM RECORDER
K894641 · BZQ
Madaus Medtec, Inc.
Anesthesiology · 182d
Cleared Jan 22, 1990
VACUSAFE DISP. VACUUM - EXTRACTION SYSTEM
K894695 · GCX
Medistad Corp.
General Hospital · 182d
Cleared Jan 22, 1990
PROTOLOGIC MODEL SER-1
K894936 · BZE
Protologic, Inc.
Anesthesiology · 172d
Cleared Jan 22, 1990
THE OPTIC BOX CONTACT LENS CASE
K895167 · LRX
The Optic Box Co., Ltd.
Ophthalmic · 153d
Cleared Jan 22, 1990
MODEL EB-22 NOISE STIK
K895200 · EWO
Eckstein Brothers, Inc.
Ear, Nose, Throat · 157d
Cleared Jan 22, 1990
TYPE FP40 DIGITAL HEARING AID ANALYZER
K895383 · ETW
Frye Electronics, Inc.
Ear, Nose, Throat · 145d
Cleared Jan 22, 1990
PATIENT EXAMINATION GLOVES
K895617 · LYY
Lit Seng Development Sdn. Bhd.
General Hospital · 125d
Cleared Jan 22, 1990
ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR
K895800 · HQR
Advanced Surgical Products, Inc.
Ophthalmic · 116d
Cleared Jan 22, 1990
PHOENIX
K895855 · KNS
Medical and Scientific Enterprises, Inc.
Gastroenterology & Urology · 112d
Cleared Jan 22, 1990
MDT/CASTLE MODEL HDX DENTAL X-RAY MACHINE
K896024 · EAP
Mdt Diagnostic Co.
Radiology · 98d
Cleared Jan 22, 1990
MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133
K896124 · IYT
Medipart Jerry Alexander
Radiology · 91d
Cleared Jan 22, 1990
DAHLBERG MODEL LH BEHIND-THE-EAR HEARING AID
K896157 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 90d
Cleared Jan 22, 1990
DAHLBERG MODEL LA BEHIND-THE-EAR HEARING AID
K896158 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 90d