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
67681–67704 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 28, 2004
VISTAKON (SENOFILCON A) SOFT CONTACT LENS
K042275 · LPL
Vistakon
Ophthalmic · 66d
Cleared Oct 28, 2004
RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE
K042388 · DQY
Radiant Medical
Cardiovascular · 56d
Cleared Oct 28, 2004
EMIT CAFFEINE ASSAY
K042407 · KLS
Dade Behring, Inc.
Toxicology · 55d
Cleared Oct 28, 2004
CENTURION SES EPIKERATOME
K042810 · HNO
Norwood Abbey , Ltd.
Ophthalmic · 16d
Cleared Oct 28, 2004
ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER)
K042831 · IYO
Reichert, Inc.
Radiology · 15d
Cleared Oct 28, 2004
SIENET COSMOS (VERSION V15A)
K042832 · LLZ
Siemens AG Medical Solutions
Radiology · 15d
Cleared Oct 28, 2004
1BD SOLOSHOT IX SYRINGE
K042934 · FMF
Becton, Dickinson & CO
General Hospital · 3d
Cleared Oct 27, 2004
FRIADENT PLUS DENTAL IMPLANT SYSTEMS
K040170 · DZE
Friadent GmbH
Dental · 275d
Cleared Oct 27, 2004
SELECT FABRICATORS, INC., AGMED TEX WOUND DRESSING
K040518 · FRO
Select Fabricators, Inc.
General & Plastic Surgery · 243d
Cleared Oct 27, 2004
GALILEO GOLD
K040574 · CBK
Hamilton Medical, Inc.
Anesthesiology · 237d
Cleared Oct 27, 2004
VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD
K041669 · FTM
Synovis Surgical Innovations
General & Plastic Surgery · 128d
Cleared Oct 27, 2004
BITECH BIPOLAR SCISSORS
K042077 · GEI
Guenter Bissinger Medizintechnik GmbH
General & Plastic Surgery · 86d
Cleared Oct 27, 2004
ANTI-SNORING/SLEEP APNEA DEVICE
K042161 · LRK
Rj & VK Bird Pty , Ltd.
Dental · 78d
Cleared Oct 27, 2004
GLUCOSE TOLERANCE BEVERAGE
K042183 · MRV
Ever Scientific
Chemistry · 77d
Cleared Oct 27, 2004
EBI CAS SPINE SPACER SYSTEM
K042268 · MQP
Ebi, L.P.
Orthopedic · 65d
Cleared Oct 27, 2004
SYNTHES (USA) LCP WRIST FUSION PLATES
K042355 · HRS
Synthes (Usa)
Orthopedic · 57d
Cleared Oct 27, 2004
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K042673 · KWP
Alphatec/Nexmed
Orthopedic · 28d
Cleared Oct 27, 2004
SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS
K042833 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Oct 26, 2004
IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA
K041102 · LJM
Immco Diagnostics, Inc.
Immunology · 182d
Cleared Oct 26, 2004
GE DATEX-OHMEDA ENGSTROM CARESTATION
K041775 · CBK
Datex-Ohmeda, Inc.
Anesthesiology · 117d
Cleared Oct 26, 2004
EXACTECH EQUINOXE SHOULDER SYSTEM
K042021 · KWS
Exactech, Inc.
Orthopedic · 90d
Cleared Oct 26, 2004
NUVASIVE MAXCESS LIGHT GUIDE
K042034 · FST
Nuvasive, Inc.
General & Plastic Surgery · 89d
Cleared Oct 26, 2004
GELATO PROPHYLAXIS PASTE
K042048 · EJR
Deepak Products, Inc.
Dental · 88d
Cleared Oct 26, 2004
QUILL SYNTHETIC ABSORBABLE BARBED SUTURE
K042075 · NEW
Quill Medical, Inc.
General & Plastic Surgery · 85d