Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
78025–78048 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 2001
CYNOSURE PHOTOGENICA VL
K012806 · GEX
Cynosure, Inc.
General & Plastic Surgery · 90d
Cleared Nov 19, 2001
RECORDING AND STIMULATING ELECTRODE
K012850 · GZL
Radionics, A Division of Tyco...
Neurology · 87d
Cleared Nov 19, 2001
DOCUMENTING LASER SLIT LAMP, DP 2010
K012873 · HJO
Bausch & Lomb, Inc.
Ophthalmic · 84d
Cleared Nov 19, 2001
FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735
K012929 · FAJ
Circon Video
Gastroenterology & Urology · 80d
Cleared Nov 19, 2001
SCREW VENT IMPLANT
K013227 · DZE
Sulzer Dental, Inc.
Dental · 53d
Cleared Nov 19, 2001
SF SH CATHETER, MODEL R65-945
K013437 · LKF
A & A Medical, Inc.
Obstetrics & Gynecology · 33d
Cleared Nov 19, 2001
HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948
K013491 · LKF
A & A Medical, Inc.
Obstetrics & Gynecology · 28d
Cleared Nov 16, 2001
FANELLI BILIARY STENT
K010601 · FGE
Cook, Inc.
Gastroenterology & Urology · 261d
Cleared Nov 16, 2001
RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS
K011121 · LJE
Rusch Intl.
Gastroenterology & Urology · 218d
Cleared Nov 16, 2001
BALLPEN SPINAL NEEDLE W/WO INTRODUCER
K011122 · BSP
Rusch Intl.
Anesthesiology · 218d
Cleared Nov 16, 2001
SNAZZY2
K011473 · INI
Shoprider Intl., Inc.
Physical Medicine · 186d
Cleared Nov 16, 2001
MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM
K011556 · KWQ
Aesculap, Inc.
Orthopedic · 179d
Cleared Nov 16, 2001
IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE
K011586 · GAA
Diametrics Medical, Inc.
Chemistry · 177d
Cleared Nov 16, 2001
POWERHEART CARDIAC RHYTHM MODULE
K012197 · MKJ
Cardiac Science, Inc.
Cardiovascular · 126d
Cleared Nov 16, 2001
AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE
K012585 · LAF
Ameditech, Inc.
Toxicology · 98d
Cleared Nov 16, 2001
DISCOVERY FACET SCREW FIXATION SYSTEM
K012773 · MRW
Depuyacromed
Orthopedic · 88d
Cleared Nov 16, 2001
JOSTRA ARTERIAL PERFUSION CANNULAE
K012774 · DWF
Jostra AG
Cardiovascular · 88d
Cleared Nov 16, 2001
DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT
K012776 · JWH
Howmedica Osteonics Corp.
Orthopedic · 88d
Cleared Nov 16, 2001
TWINTRODE ELC 134 ELECTRODE
K012785 · LNS
Healthtronics Surgical Services, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 16, 2001
CYNOSURE PHOTOGENICA ER
K012790 · GEX
Cynosure, Inc.
General & Plastic Surgery · 88d
Cleared Nov 16, 2001
INTEX SCREW
K012798 · HWC
Biomet, Inc.
Orthopedic · 87d
Cleared Nov 16, 2001
SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9
K012819 · KGO
Semperit Technische Produkte Gesellshaft
General Hospital · 85d
Cleared Nov 16, 2001
INTUITIVE SURGICAL BIPOLAR FORCEPS
K012833 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 85d
Cleared Nov 16, 2001
SMART GLOVE STERILE NITRILE EXAM GLOVE
K012853 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 84d