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
58969–58992 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 2007
MODIFICATION TO: ARTHROCARE ARTHROWANDS
K071963 · GEI
Arthrocare Corp.
General & Plastic Surgery · 22d
Cleared Aug 07, 2007
QUANTUM DIREX SYSTEM
K072010 · KPR
Quantum Medical Imaging, LLC
Radiology · 15d
Cleared Aug 06, 2007
BENZ-G 4X HIOXIFILCON D
K062854 · LPL
Benz Research and Development Corp.
Ophthalmic · 315d
Cleared Aug 06, 2007
EKOS MICRO-INFUSION SYSTEM
K063620 · QEY
Ekos Corp.
Cardiovascular · 244d
Cleared Aug 06, 2007
SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC
K070117 · MEG
Dolomite Biotech Sdn Bhd
General Hospital · 206d
Cleared Aug 06, 2007
THROMBI-PASTE THROMBIN/GELATIN POWDER PASTE HEMOSTAT
K070938 · QSX
Vascular Solutions, Inc.
General & Plastic Surgery · 124d
Cleared Aug 06, 2007
POLARIS BE RODS
K071377 · KWP
Biomet Spine
Orthopedic · 81d
Cleared Aug 06, 2007
NUVASIVE OCT SYSTEM
K071435 · MNI
Nuvasive, Inc.
Orthopedic · 75d
Cleared Aug 06, 2007
MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE...
K071505 · GWM
Integra LifeSciences Corporation
Neurology · 66d
Cleared Aug 06, 2007
HEMCON CHITOFLEX-SURGICAL DRESSING
K071519 · QSY
Hemcon, Inc.
General & Plastic Surgery · 63d
Cleared Aug 06, 2007
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K071685 · LYZ
Langfang Huilong Plastic Product Co.,...
General Hospital · 47d
Cleared Aug 06, 2007
ORTHOMEND SOFT TISSUE MATRIX
K071807 · FTM
Tei Biosciences, Inc.
General & Plastic Surgery · 35d
Cleared Aug 06, 2007
LULLABY
K071828 · LBI
Ge Healthcare Clinical Systems
General Hospital · 34d
Cleared Aug 06, 2007
QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL
K071989 · NEW
Surgical Specialties Corp
General & Plastic Surgery · 17d
Cleared Aug 06, 2007
OSTEOGRAF/D-700
K072056 · LYC
Dentsply International, Inc.
Dental · 11d
Cleared Aug 06, 2007
OSTEOGRAF/LD-300
K072057 · LYC
Dentsply International, Inc.
Dental · 11d
Cleared Aug 04, 2007
DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A
K071767 · NBC
Dade Behring, Inc.
Chemistry · 36d
Cleared Aug 03, 2007
AXIS-V MONOCHROME 5 MP DISPLAY
K063066 · LLZ
National Display Systems
Radiology · 301d
Cleared Aug 03, 2007
ALLEVYN AG DRESSING
K063835 · FRO
Smith & Nephew, Inc.
General & Plastic Surgery · 220d
Cleared Aug 03, 2007
SWABBABLE CAP, MODEL 60205
K070163 · ODI
Baxa Corp.
General Hospital · 198d
Cleared Aug 03, 2007
NEUROPORT ELECTRODE
K070272 · GZL
Cyberkinetics Neurotechnology...
Neurology · 186d
Cleared Aug 03, 2007
ADVIA CHEMISTRY ENZYMATIC CREATININE_2
K070727 · JFY
Siemens Medical Solutions Diagnostics
Chemistry · 141d
Cleared Aug 03, 2007
MODIFICATION TO: ARTHREX INTERFERENCE SCREW
K071176 · MAI
Arthrex, Inc.
Orthopedic · 98d
Cleared Aug 03, 2007
UNIRING - ANNULOPLASTY RING WITH SIZERS
K071281 · KRH
Peters Surgical
Cardiovascular · 88d