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
62017–62040 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 2006
VERTE-STACK SPINAL SYSTEM
K061938 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Aug 09, 2006
ENDO CAR COMPRESSION ANASTOMOSIS RING (CAR)
K062008 · FZP
Niti Medical Technologies , Ltd.
General & Plastic Surgery · 23d
Cleared Aug 09, 2006
EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135
K062126 · DQO
Biosphere Medical, Inc.
Cardiovascular · 14d
Cleared Aug 08, 2006
ORBITAL TISSUE EXPANDER (OTE)
K060151 · NFM
Innovia, LLC
Ophthalmic · 200d
Cleared Aug 08, 2006
HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
K060318 · CIT
Horiba Abx
Chemistry · 181d
Cleared Aug 08, 2006
ONLINE VALPROIC ACID
K060690 · LEG
Roche Diagnostics Corp.
Toxicology · 146d
Cleared Aug 08, 2006
DPC T60I KUSTI, MODEL 984248
K061107 · CEM
Thermo Electron OY
Chemistry · 110d
Cleared Aug 08, 2006
SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS
K061500 · DZE
Sic Invent AG
Dental · 69d
Cleared Aug 08, 2006
COMPUDENT STA
K061904 · EJI
Milestone Scientific, Inc.
Dental · 34d
Cleared Aug 08, 2006
POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION
K062091 · BTT
Porous Media Corp.
Anesthesiology · 15d
Cleared Aug 08, 2006
COMCASET SAFETY IV CATHETER
K062108 · FOZ
Pitango Medical, Ltd.
General Hospital · 15d
Cleared Aug 07, 2006
TREP-SURE TREPONEMAL ANTIBODY EIA
K053570 · LIP
Phoenix Biotech Corp.
Microbiology · 228d
Cleared Aug 07, 2006
ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000
K060355 · DJC
Acro Biotech, LLC
Toxicology · 175d
Cleared Aug 07, 2006
RAPIDONE-BUPRENORPHINE TEST
K060760 · DJG
American Bio Medica Corp.
Toxicology · 139d
Cleared Aug 07, 2006
ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC
K060810 · DKZ
Ind Diagnostic, Inc.
Toxicology · 136d
Cleared Aug 07, 2006
PARAGOLFER
K060936 · IPL
Parabasetec, GmbH
Physical Medicine · 124d
Cleared Aug 07, 2006
CO-1000 COLPOSCOPE, MULTIPLE
K061306 · HEX
Gynex Corp.
Obstetrics & Gynecology · 89d
Cleared Aug 07, 2006
MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE
K061404 · OKS
Fci Ophthalmics, Inc.
Ophthalmic · 80d
Cleared Aug 07, 2006
GORE PRECLUDE VESSEL GUARD
K061727 · MFX
W.L. Gore & Associates, Inc.
Cardiovascular · 49d
Cleared Aug 07, 2006
MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM
K061755 · IYO
Esaote Europe B.V.
Radiology · 47d
Cleared Aug 07, 2006
DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR
K061793 · JIY
Dade Behring, Inc.
Chemistry · 42d
Cleared Aug 07, 2006
2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS
K061801 · JDR
Arthrotek, Inc.
Orthopedic · 42d
Cleared Aug 07, 2006
COUGAR WHEELCHAIR
K061810 · IOR
R82 A/S
Physical Medicine · 41d
Cleared Aug 07, 2006
MEDCHANNEL HTS SYSTEM
K061831 · IYN
Medchannel, LLC
Radiology · 40d