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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
93721–93744 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 23, 1997
SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM
K965139 · HAW
Carl Zeiss, Inc.
Neurology · 121d
Cleared Apr 23, 1997
MONARCH IOL DELIVERY SYSTEM
K970033 · KYB
Alcon Laboratories
Ophthalmic · 110d
Cleared Apr 23, 1997
KENDALL HYDROPHILIC POWDER WOUND DRESSING
K970266 · KGN
Kendall Healthcare Products Co....
General & Plastic Surgery · 90d
Cleared Apr 23, 1997
IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW
K970292 · MBI
Influence, Inc.
Orthopedic · 89d
Cleared Apr 23, 1997
MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT
K970341 · LIS
Medtronic PS Medical
General Hospital · 84d
Cleared Apr 23, 1997
PUNCTUAL OCCLUDER
K970631 · LZU
Odyssey Medical, Inc.
Ophthalmic · 63d
Cleared Apr 23, 1997
BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE
K970930 · DYJ
Cleft Palate Appliances, Inc.
Dental · 41d
Cleared Apr 23, 1997
SMITH & NEPHEW MIS INSTRUMENTS
K970949 · GCJ
Smith & Nephew Endoscopy, Inc.
General & Plastic Surgery · 40d
Cleared Apr 23, 1997
KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET
K970969 · KOB
The Kendal Co.
Gastroenterology & Urology · 37d
Cleared Apr 23, 1997
LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS
K971014 · JJX
Lifescan, Inc.
Chemistry · 34d
Cleared Apr 23, 1997
LIQUID LIGAND 1,2,3
K971071 · JJY
Chiron Diagnostics Corp.
Chemistry · 30d
Cleared Apr 23, 1997
QA-ES
K971092 · GEI
Smith
General & Plastic Surgery · 28d
Cleared Apr 22, 1997
VENTANA ANTI-MELANOMA PRIMARY ANTIBODY
K941170 · DEH
Ventana Medical Systems, Inc.
Immunology · 1135d
Cleared Apr 22, 1997
CARD GUARD MODEL CG-900
K960553 · HGM
Card Guard Scientific Survival , Ltd.
Obstetrics & Gynecology · 439d
Cleared Apr 22, 1997
COAGUCHEK PST SYSTEM
K962571 · GJS
Boehringer Mannheim Corp.
Hematology · 295d
Cleared Apr 22, 1997
IMT LOUPE-COLPOSCOPE
K963593 · HEX
Inventive Medical Technology
Obstetrics & Gynecology · 225d
Cleared Apr 22, 1997
TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT
K963731 · DWJ
Enthermics Medical Systems, Inc.
Cardiovascular · 217d
Cleared Apr 22, 1997
HYDRAGEL 15 HB A1C KIT
K963844 · LCP
Morax
Hematology · 209d
Cleared Apr 22, 1997
PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
K963850 · CAC
Deknatel, Inc.
Anesthesiology · 209d
Cleared Apr 22, 1997
SONOS 2000, SONOS 2500 (M2406 A)
K964309 · IYN
Hewlett-Packard Co.
Radiology · 175d
Cleared Apr 22, 1997
RESECTOSCOPE CUTTING LOOP ELECTRODE
K964365 · FAS
Omnitech Systems, Inc.
Gastroenterology & Urology · 172d
Cleared Apr 22, 1997
EUDERMIC HYPOALLERGENIC SURGICAL GLOVES/EUDERMIC SURGICAL GLOVES (VARIOUS)
K964440 · KGO
Maxxim Medical
General Hospital · 167d
Cleared Apr 22, 1997
PROSELECT 3 PERIDONTAL THERAPY SYSTEM
K964596 · ELC
Professional Dental Mfg., Inc.
Dental · 155d
Cleared Apr 22, 1997
RONIX II ROTARY ULTRASONIC SURGICAL SYSTEM
K964742 · LFL
Aziz Y. Anis, M.D.
General & Plastic Surgery · 147d