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
94249–94272 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 11, 1997
KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE
K970427 · FGB
Karl Storz Endoscopy
Gastroenterology & Urology · 35d
Cleared Mar 11, 1997
ADAPTIVE COMPRESSION - CLASS D/ CLASS D AGCI
K970430 · ESD
Midwest City Hearing Aid Center
Ear, Nose, Throat · 35d
Cleared Mar 11, 1997
URIC ACID (LIQUID) REAGENT SET
K970560 · KNK
Pointe Scientific, Inc.,
Chemistry · 26d
Cleared Mar 10, 1997
PULSEMASTER
K961269 · GEX
American Dental Technologies, Inc.
General & Plastic Surgery · 342d
Cleared Mar 10, 1997
IMMULITE OPIATES SCREEN/CONTROL MODULE
K962323 · DJG
Diagnostic Products Corp.
Toxicology · 266d
Cleared Mar 10, 1997
NASP HYDROCOLLOID DRESSING (REGULAR OR THIN)
K964231 · KMF
North American Sterilization &...
General & Plastic Surgery · 138d
Cleared Mar 10, 1997
R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM
K964538 · LJT
Boston Scientific Corp
General Hospital · 118d
Cleared Mar 10, 1997
PVK-720ST ENDOCAVITARY TRANSDUCER
K964865 · ITX
Toshiba America Medical Systems, In.C
Radiology · 96d
Cleared Mar 10, 1997
ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS
K964909 · ETB
Xomed, Inc.
Ear, Nose, Throat · 91d