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
130465–130488 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 1989
DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI.
K892905 · CIG
Catachem, Inc.
Chemistry · 60d
Cleared Jun 19, 1989
LOW POWDER SINGLE USE LATEX EXAM GLOVES
K892975 · LYY
Phoenix Medical Technology, Inc.
General Hospital · 68d
Cleared Jun 19, 1989
LATEX EXAMINATION GLOVES
K893015 · LYY
Universal Gloves Private , Ltd.
General Hospital · 68d
Cleared Jun 19, 1989
CHAMP-PAQ LATEX PATIENT EXAMINATION GLOVES
K893107 · LYY
Winmed Instruments Mfg. Corp.
General Hospital · 66d
Cleared Jun 19, 1989
WARDEN LATEX EXAMINATION GLOVES
K893179 · LYY
Kuo Jun Ent. Co., Ltd.
General Hospital · 48d
Cleared Jun 19, 1989
REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171
K893211 · CEF
Helena Laboratories
Chemistry · 53d
Cleared Jun 19, 1989
LATEX EXAMINATION GLOVES
K893268 · LYY
Regulus Intl. Corp.
General Hospital · 63d
Cleared Jun 19, 1989
CHOLESTEROL REAGENT SET
K893479 · CHH
American Monitor Corp.
Chemistry · 46d
Cleared Jun 16, 1989
AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL
K881196 · IPF
Biometer Intl. A/S
Physical Medicine · 452d
Cleared Jun 16, 1989
OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL
K884884 · ETA
Porex Technologies Corp. of Georgia
Ear, Nose, Throat · 206d
Cleared Jun 16, 1989
ALPHA MODEL I ITE HEARING AID
K890271 · ESD
Alpha Instruments, Inc.
Ear, Nose, Throat · 149d
Cleared Jun 16, 1989
MAX-1 (EXERCISE ELECTROCARDIOGRAPH)
K890323 · DSI
Marquette Electronics, Inc.
Cardiovascular · 144d
Cleared Jun 16, 1989
IMPLANT PARALLELING DEVICE (I.P.D.)
K890433 · EFB
J.E. Josephson, D.M.D.
Dental · 140d
Cleared Jun 16, 1989
ADEL - MODEL 986 INFANT WARMER
K890476 · FMZ
Adel Medical , Ltd.
General Hospital · 136d
Cleared Jun 16, 1989
STERILE IRRIGATION TRAYS
K890728 · KYZ
Cypress Medical Products, Ltd.
General Hospital · 123d
Cleared Jun 16, 1989
VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M
K891095 · DHA
Leeco Diagnostics, Inc.
Chemistry · 106d
Cleared Jun 16, 1989
VIS-DISK HCG (EIA) JPL-041M
K891096 · DHA
Leeco Diagnostics, Inc.
Chemistry · 106d
Cleared Jun 16, 1989
PRIMUS MODEL CLC 330
K891235 · LCP
Primus, Inc.
Hematology · 101d
Cleared Jun 16, 1989
MICROTRAK EIA AUTOREADER
K891270 · JJQ
Syva Co.
Chemistry · 99d
Cleared Jun 16, 1989
THE CEN-SLIDE(TM) CENTRIFUGE TUBE
K891604 · KEW
Davstar California, Inc.
Pathology · 88d
Cleared Jun 16, 1989
PUL-TRON 100K PROFESSIONAL SPIROMETER
K891672 · BZG
Advanced Medical Systems, Inc.
Anesthesiology · 87d
Cleared Jun 16, 1989
THE SMILE MACHINE
K891694 · JEQ
Brilliant Industries, Inc.
Dental · 86d
Cleared Jun 16, 1989
AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325
K891922 · CHH
American Research Products Co.
Chemistry · 81d
Cleared Jun 16, 1989
DEX-CELL HYSTEROSCOPY FLUID DELIVERY DEVICE
K892001 · HIG
Dexide, Inc.
Obstetrics & Gynecology · 80d