FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
126769–126792 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 26, 1990
MODEL 2121-64
K901242 · LNH
Medical Advances, Inc.
Radiology · 42d
Cleared Apr 26, 1990
HEMACON-DOA(TM) DRUGS OF ABUSE WHOLE BLOOD CONTROL
K901276 · DIT
Diagnostic Products Corp.
Toxicology · 38d
Cleared Apr 26, 1990
MODEL 2121-21, TMJ SURFACE COIL
K901305 · LNH
Medical Advances, Inc.
Radiology · 37d
Cleared Apr 26, 1990
U.V. SUNLAMP 95UF-II
K901324 · FTC
Light Sources, Inc.
General & Plastic Surgery · 36d
Cleared Apr 26, 1990
MODEL 6000-21
K901384 · LNH
Medical Advances, Inc.
Radiology · 31d
Cleared Apr 26, 1990
E/LUMINA(TM)/ALLEGRO LITE(TM) LUMINESCENCE MEASURE
K901542 · JJQ
Source Scientific Systems, Inc.
Chemistry · 24d
Cleared Apr 26, 1990
NOVA LITE(TM) ANA MK
K901595 · DHN
Inova Diagnostics, Inc.
Immunology · 21d
Cleared Apr 26, 1990
AMBU OXYGEN REGULATOR
K901623 · CAN
Flotec, Inc.
Anesthesiology · 20d
Cleared Apr 26, 1990
RESUBMITTED MODIFIED RUBALEX
K901637 · LQN
Orion Corp.
Microbiology · 17d
Cleared Apr 26, 1990
APOLIPOPROTEIN A-I (APO A-I)
K901675 · DEL
Sigma Chemical Co.
Immunology · 16d
Cleared Apr 25, 1990
LINEAR LIFT DEVICE
K881676 · IKK
Cybex
Physical Medicine · 736d
Cleared Apr 25, 1990
CYBEX BACK TESTING AND REHABILITATION SYSTEM
K881681 · IKK
Cybex
Physical Medicine · 736d
Cleared Apr 25, 1990
BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM
K894184 · JDN
Biedermann Motech GmbH
Orthopedic · 313d
Cleared Apr 25, 1990
PHYCON ALL SILICONE BALLOON CATHETER
K894883 · EZL
Vitaid, Ltd.
Gastroenterology & Urology · 267d
Cleared Apr 25, 1990
S-70 PORTABLE DENTAL X-RAY SYSTEM
K894935 · EHD
Lorad Medical Systems, Inc.
Radiology · 265d
Cleared Apr 25, 1990
SAFE AID DEVICE IMPOTENCE DEVICE
K896357 · LKY
Dr. John P. March
Gastroenterology & Urology · 170d
Cleared Apr 25, 1990
HAEMOTRONIC BLOOD LINE SET
K896407 · FJK
Healthcare Suppliers, Inc.
Gastroenterology & Urology · 169d
Cleared Apr 25, 1990
STRATO INDWELLING CATHETER
K896598 · LJS
Strato Medical Corp.
General Hospital · 155d
Cleared Apr 25, 1990
LATEX DENTAL & EXAMINATION GLOVES
K896881 · LYY
American Intl. Health Industries...
General Hospital · 138d
Cleared Apr 25, 1990
NEOPHOR-MC
K900363 · EGJ
L.S. Scientific
Physical Medicine · 90d
Cleared Apr 25, 1990
HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140
K900618 · KNG
Huntleigh Technology, Inc.
Obstetrics & Gynecology · 76d
Cleared Apr 25, 1990
FLUID SOAKERSHIELD
K900643 · KME
Infection Control Products, Inc.
General Hospital · 75d
Cleared Apr 25, 1990
WORKING CHANNEL VALVE
K900781 · FFY
Applied Urology, Inc.
Gastroenterology & Urology · 64d
Cleared Apr 25, 1990
DUAL LUMEN SUB-CLAVIAN CATHETERS DLSC 600S & 800S
K900803 · LFJ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 64d