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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
45985–46008 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 09, 2011
TELAMON PEEK SPINAL SYSTEM
K110562 · MAX
Medtronic Sofamor Danek USA
Orthopedic · 254d
Cleared Nov 09, 2011
HUMELOCK CEMENTED SHOULDER PROSTHESIS
K111097 · HSD
Fx Solutions
Orthopedic · 203d
Cleared Nov 09, 2011
T:SLIM (TM) INSULIN DELIVERY SYSTEM
K111210 · LZG
Tandem Diabetes Care, Inc.
General Hospital · 194d
Cleared Nov 09, 2011
ASIMANAGER - AT
K111356 · JQT
Arlington Scientific, Inc.
Microbiology · 177d
Cleared Nov 09, 2011
SWEETSPOT DIABETES DATA MANAGEMENT SERVICE
K111509 · NBW
Sweetspot Diabetes Care, Inc.
Chemistry · 161d
Cleared Nov 09, 2011
FD TENS 2050 OR SLIDE TENS MODEL FD2050
K111645 · GZJ
Fuji Dynamics , Ltd.
Neurology · 149d
Cleared Nov 09, 2011
ASA 'MPHI FAMILY DIODE LASER
K111901 · ILY
Cynosure, Inc.
Physical Medicine · 127d
Cleared Nov 09, 2011
CERCON HT
K112152 · EIH
Dentsply International, Inc.
Dental · 105d
Cleared Nov 09, 2011
PATIENT MONITOR
K112190 · MHX
Mediana Co., Ltd.
Cardiovascular · 103d
Cleared Nov 09, 2011
RUBICON SUPPORT CATHETER
K112303 · DQY
Boston Scientific
Cardiovascular · 90d
Cleared Nov 09, 2011
CPK REAGENT
K112416 · CGS
Vital Diagnostics (Manufacturing) Ptyltd
Chemistry · 79d
Cleared Nov 09, 2011
INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER
K112601 · MWJ
Intricon Datrix Corporation
Cardiovascular · 63d
Cleared Nov 09, 2011
ENSITE VELOCITY SYSTEM V.3.0
K112688 · DQK
St Jude Medical
Cardiovascular · 55d
Cleared Nov 09, 2011
CATHETER CONNECTIONS' DUALCAP DUO
K112985 · QBP
Catheter Connections, Inc.
General Hospital · 34d
Cleared Nov 09, 2011
POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50...
K112988 · LYY
Northstar Healthcare Holdings Limited
General Hospital · 34d
Cleared Nov 09, 2011
AXERA ACCESS SYSTEM
K113110 · DYB
Arstasis, Inc.
Cardiovascular · 20d
Cleared Nov 08, 2011
ENTERAL FEEDING BAG AND SETS
K102741 · KNT
Shandong Weigao Group Medical Polymer...
Gastroenterology & Urology · 412d
Cleared Nov 08, 2011
PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT
K103788 · CFR
HORIBA ABX SAS
Chemistry · 316d
Cleared Nov 08, 2011
FM20
K110612 · HGM
Mediana Co., Ltd.
Obstetrics & Gynecology · 250d
Cleared Nov 08, 2011
CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A)
K111267 · LPL
Abbconcise Optical Group, LLC
Ophthalmic · 188d
Cleared Nov 08, 2011
FIR HEAT THERAPHY SYSYEMS
K111273 · IRT
Shenzhen Anpan Technology Co., Ltd.
Physical Medicine · 188d
Cleared Nov 08, 2011
SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES
K111615 · JWY
Trek Diagnostic Systems
Microbiology · 151d
Cleared Nov 08, 2011
TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC
K111692 · NEU
Somatex Medical Technologies GmbH
General & Plastic Surgery · 145d
Cleared Nov 08, 2011
ACKERMANN EUROPCLIP
K111930 · FZP
Ackermann Instrumente GmbH
General & Plastic Surgery · 124d