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

Filters: Cleared only ×
175,820 results
99361–99384 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 1996
PLATFORM ONESTEP PREGNANCY HOME TEST
K960117 · LCX
Syntron Bioresearch, Inc.
Chemistry · 68d
Cleared Mar 19, 1996
VIVASPIN 4 10,000 MW
K960298 · JJH
Vivascience, Inc.
Chemistry · 57d
Cleared Mar 19, 1996
T-3 MICROWELL EIA MODEL 7013
K960412 · CDP
Biomerica, Inc.
Chemistry · 50d
Cleared Mar 19, 1996
SELFCARE EARLY PREGNANCY TEST
K960436 · LCX
Selfcare, Inc.
Chemistry · 48d
Cleared Mar 19, 1996
NON PRESCRIPTION SUN GLASSES
K960650 · HQY
Solovision Optical, Inc.
Ophthalmic · 78d
Cleared Mar 18, 1996
ZYMED HOLTER SCANNER MODEL 2010
K955015 · DQK
Zymed Medical Instrumentation
Cardiovascular · 138d
Cleared Mar 18, 1996
TRUPEAK PEAK FLOW METER
K955234 · BZH
Monaghan Medical Corp.
Anesthesiology · 125d
Cleared Mar 18, 1996
TAS PTONE
K955843 · GJS
Cardiovascular Diagnostic Services
Hematology · 83d
Cleared Mar 18, 1996
PRACTIFIX EXTERNAL FIXATION SYSTEM
K960014 · KTT
Orthopaedic Innovations, Inc.
Orthopedic · 76d
Cleared Mar 18, 1996
KIRSHNER WIRES (K-WIRE) & STEINMANN PINS
K960023 · JDW
Promex, Inc.
Orthopedic · 76d
Cleared Mar 18, 1996
MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOTATION MATRESS
K960411 · FNM
Invacare Corp.
General Hospital · 49d
Cleared Mar 18, 1996
PRIMIDONE EIA TEST
K960526 · DJP
Diagnostic Reagents, Inc.
Toxicology · 41d
Cleared Mar 15, 1996
FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE
K945847 · DZE
Friatec Medical Inc., USA
Dental · 471d
Cleared Mar 15, 1996
FRIALIT(R)-2 DENTAL IMPLANT
K945848 · DZE
Friatec Medical Inc., USA
Dental · 471d
Cleared Mar 15, 1996
FRIALIT(R)-2 STEPPED CYLINDER WITH FRIOS(R) TI-COATING
K945849 · DZE
Friatec Medical Inc., USA
Dental · 471d
Cleared Mar 15, 1996
TETRAD 2300 E/U ULTRASOUNG IMAGING SYSTEM
K946277 · IYN
Tetra Corp.
Radiology · 444d
Cleared Mar 15, 1996
NEXGEN COMPLETE KNEE SOLUTION 9MM ARTICULAR SURFACE
K951185 · JWH
Zimmer, Inc.
Orthopedic · 365d
Cleared Mar 15, 1996
DFI-1000 AND DVS-475 IMAGING DEVICES
K951261 · JAA
Nical
Radiology · 360d
Cleared Mar 15, 1996
RT55 DIAGNOSTIC ULTRASOUND SYSTEM
K953752 · IYO
General Electric Co.
Radiology · 218d
Cleared Mar 15, 1996
LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR
K953835 · DTZ
Dideco S.R.L.
Cardiovascular · 212d
Cleared Mar 15, 1996
X-RAY VISIONS
K954172 · LMD
Image Visions, LLC
Radiology · 192d
Cleared Mar 15, 1996
CADPLAN BT
K954467 · JAQ
Varian Assoc., Inc.
Radiology · 171d
Cleared Mar 15, 1996
PRE POWDERED LATEX EXAMINATION GLOVES
K954487 · LYY
Ganz Industries Sdn. Bhd.
General Hospital · 170d
Cleared Mar 15, 1996
ENDOSSEOUS DENTAL IMPLANT & ACCESSORIES
K955281 · DZE
The Straumann Co.
Dental · 120d