FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
94753–94776 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 1997
LIFESTYLE 4-VUE (POLYMACON) HYDROPHILIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR
K963001 · LPL
Permeable Technologies, Inc.
Ophthalmic · 221d
Cleared Mar 11, 1997
VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION
K963273 · KPS
Smv America
Radiology · 203d
Cleared Mar 11, 1997
VESSEL DILATOR
K963388 · DRE
Maxxim Medical
Cardiovascular · 195d
Cleared Mar 11, 1997
QUANTITATIVE SENTINEL SYSTEM
K963608 · HGM
Quantitative Medicine, Inc.
Obstetrics & Gynecology · 182d
Cleared Mar 11, 1997
EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND...
K963787 · DRX
Conmedcorp
Cardiovascular · 172d
Cleared Mar 11, 1997
SMARTGUIDE
K963894 · FCG
Ferguson Medical
Gastroenterology & Urology · 165d
Cleared Mar 11, 1997
CYTOPLAST GBR
K964342 · LYC
Osteogenics Co.
Dental · 131d
Cleared Mar 11, 1997
ULTRAFREE STERILE LATEX POWDER-FREE SURGICAL GLOVES
K964474 · KGO
Allegiance Healthcare Corp.
General Hospital · 124d
Cleared Mar 11, 1997
FORCE ARGON II ARGON ENHANCED ELECTROSURGICAL SYSTEM
K964636 · GEI
Valleylab, Inc.
General & Plastic Surgery · 112d
Cleared Mar 11, 1997
CONTACT LENSES METRO-G 3X (HIOXIFILCON B)
K964902 · LPL
Metro Optics of Austin, Inc.
Ophthalmic · 95d
Cleared Mar 11, 1997
POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER
K964979 · CAH
Porous Media Corp.
General Hospital · 89d
Cleared Mar 11, 1997
C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNER
K965004 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 85d
Cleared Mar 11, 1997
LIFESTYLE BREAK THRU (POLYMACON)
K965012 · LPL
The Lifestyle Co., Inc.
Ophthalmic · 85d
Cleared Mar 11, 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT
K965058 · CDP
Nichols Institute Diagnostics
Chemistry · 83d
Cleared Mar 11, 1997
SOOTHING WATER-FILLED TEETHER
K965082 · KKO
Consolidated Stores Corp.
Dental · 82d
Cleared Mar 11, 1997
MEDLINE ADMISSION KITS
K965107 · FXX
Medline Industries, Inc.
General Hospital · 81d
Cleared Mar 11, 1997
ROCCOBAROCCO & PRO-DYNAMIX
K965170 · HQY
Michelangelo, Inc.
Ophthalmic · 77d
Cleared Mar 11, 1997
VISTA BRITE TIP CATHETERS
K965211 · DQY
Cordis Corp.
Cardiovascular · 74d
Cleared Mar 11, 1997
SERIES 7600 MOBILE DIGITAL C-ARM
K970063 · OWB
Ge Dec Medical Systems
Radiology · 63d
Cleared Mar 11, 1997
PROXIMATE DISPOSABLE SKIN STAPLER
K970079 · GAG
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 61d
Cleared Mar 11, 1997
DIFFUSER PANEL
K970240 · IXC
Focused Viewer, Inc.
Radiology · 48d
Cleared Mar 11, 1997
INTRAORAL MANDIBULAR DISTRACTION DEVICE
K970256 · JEY
Medicon EG
Dental · 47d
Cleared Mar 11, 1997
PREPOWDERED LATEX EXAMINATION GLOVE
K970313 · LYY
Besglove Healthcare Sdn. Bhd.
General Hospital · 43d
Cleared Mar 11, 1997
GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS
K970372 · FDF
Precision Endoscopy of America, Inc.
Gastroenterology & Urology · 39d