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
58921–58944 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 2007
1.3M MONOCHROME LCD MONITOR MDL1908A
K072066 · LLZ
Totoku Electric Co., Ltd.
Radiology · 18d
Cleared Aug 14, 2007
IGUIDE SYSTEM
K072079 · IYE
Medical Intelligence...
Radiology · 15d
Cleared Aug 13, 2007
TESLA NIBP
K062974 · DXN
Mammendorfer Institut Fur Physik Und...
Cardiovascular · 318d
Cleared Aug 13, 2007
FINGERTIP PULSE OXIMETER MD300C
K070371 · DQA
Beijing Choice Electronic Technololgy...
Anesthesiology · 186d
Cleared Aug 13, 2007
IFS BONE FIXATION DEVICES
K071035 · HWC
Internal Fixation Systems, Inc.
Orthopedic · 123d
Cleared Aug 13, 2007
MODIFICATION TO SOLAR GI
K071094 · FFX
Medical Measurement Systems B.V.
Gastroenterology & Urology · 117d
Cleared Aug 10, 2007
STD MED PRIMO PORT
K070911 · LJT
Std Med, Inc.
General Hospital · 130d
Cleared Aug 10, 2007
SELF-LIGHT DISPOSABLE ANOSCOPE
K070913 · FER
Sapimed S.P.A.
Gastroenterology & Urology · 130d
Cleared Aug 10, 2007
CAMLOG LOGFIT PROSTHETIC SYSTEM
K071213 · NHA
Altatec GmbH
Dental · 101d
Cleared Aug 10, 2007
MEMO 3D SEMIRIGID ANNULOPLASTY RING
K071327 · KRH
Sorin Biomedica Cardio S.R.L.
Cardiovascular · 91d
Cleared Aug 10, 2007
NANO-BOND II ADHESIVE SYSTEM
K071500 · KLE
Pentron Clinical Technologies
Dental · 71d
Cleared Aug 10, 2007
RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X
K071520 · MBI
Core Essence Orthopaedics, LLC
Orthopedic · 67d
Cleared Aug 10, 2007
XTRACT CATHETER SYSTEM
K071529 · QEZ
Lumen Biomedical, Inc.
Cardiovascular · 66d
Cleared Aug 10, 2007
STRYKER EXTERNAL FIXATION SYSTEM
K071628 · MQN
Stryker Cmf
Dental · 57d
Cleared Aug 10, 2007
DEEP BLUE
K071722 · EBZ
E.M.S Electro Medical Systems S.A
Dental · 49d
Cleared Aug 10, 2007
ENDOWAVE INFUSION SYSTEM
K071933 · QEY
Ekos Corp.
Cardiovascular · 28d
Cleared Aug 10, 2007
SERENITY PRO PSF SYSTEM
K071943 · GEX
Inolase 2002, Ltd.
General & Plastic Surgery · 28d
Cleared Aug 10, 2007
PHILIPS MP2 AND X2 INTELLIVUE PATIENT MONITORS
K072070 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 11d
Cleared Aug 10, 2007
AIRLIFE NEBULIZER CAP
K072119 · CAF
Cardinalhealth
Anesthesiology · 9d
Cleared Aug 09, 2007
GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM
K063771 · NBW
Arkray Factory USA, Inc.
Chemistry · 231d
Cleared Aug 09, 2007
PEEK KNOTLESS ANCHORS
K070389 · HWC
Biomet Sports Medicine, Inc.
Orthopedic · 181d
Cleared Aug 09, 2007
HEALIX ANCHOR
K071481 · HWC
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 72d
Cleared Aug 09, 2007
CODIAGNOSTIX (R) 5.72
K071636 · LLZ
Ivs Solutions AG
Radiology · 55d
Cleared Aug 09, 2007
GC-ZIRCONIA
K071674 · EIH
GC America, Inc.
Dental · 51d