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
62665–62688 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 2006
PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)
K060189 · GXZ
Ives Eeg Solutions, Inc.
Neurology · 126d
Cleared May 30, 2006
AUTOFUSER
K060258 · MEB
Ace Medical Us, LLC
General Hospital · 118d
Cleared May 30, 2006
REFA, PHYSIOLOGICAL AMPLIFIER
K060374 · GWL
Tms International BV
Neurology · 106d
Cleared May 30, 2006
HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE
K060449 · DQX
Guidant Corporation
Cardiovascular · 98d
Cleared May 30, 2006
DPOAE20 , ECLIPSE
K060539 · EWO
Interacoustics A/S, Assens
Ear, Nose, Throat · 90d
Cleared May 30, 2006
CLEARADEX GEL
K060561 · KHJ
Cambridgemed
Ear, Nose, Throat · 88d
Cleared May 30, 2006
PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS...
K060645 · DKB
Roche Diagnostics Corp.
Toxicology · 81d
Cleared May 30, 2006
COMPREHENSIVE PRIMARY SHOULDER STEMS
K060692 · MBF
Biomet Manufacturing Corp
Orthopedic · 76d
Cleared May 30, 2006
NOD CHEMISTRY CONTROL
K060850 · JJY
Bioresource Technology, Inc.
Chemistry · 63d
Cleared May 30, 2006
OXLIFE FREEDOM FIVE OXYGEN CONCENTRATORS, MODEL KXF5
K060922 · CAW
Oxlife, LLC
Anesthesiology · 56d
Cleared May 30, 2006
CARDIOIMMUNE XL CARDIAC MARKER CONTROL
K061196 · JJY
Microgenics Corp.
Chemistry · 32d
Cleared May 30, 2006
DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087
K061201 · FCK
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 29d
Cleared May 30, 2006
CARDIQ FUSION
K061370 · JAK
Ge Healthcare
Radiology · 13d
Cleared May 30, 2006
CENTRICITY AW SUITE OPTION
K061372 · LLZ
Ge Healthcare Information Technologies
Radiology · 13d
Cleared May 30, 2006
QLAB QUANTIFICATION SOFTWARE
K061396 · LLZ
Philips Ultrasound, Inc.
Radiology · 11d
Cleared May 26, 2006
RINSENDO
K052271 · NYL
Air Techniques, Inc.
Dental · 280d
Cleared May 26, 2006
LAPARO-THORACO VIDEOSCOPE XLTF-VAW
K053382 · GCJ
Olympus Medical Systems Corporation
General & Plastic Surgery · 172d
Cleared May 26, 2006
BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30
K060546 · MNS
Breas Medical AB
Anesthesiology · 86d
Cleared May 26, 2006
NEXGEN COMPLETE KNEE SOLUTION ULTRACONGRUENT (UC-FLEX) FIXED BEARING...
K060722 · JWH
Zimmer, Inc.
Orthopedic · 70d
Cleared May 26, 2006
DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM
K060735 · ITH
Axiom Worldwide, Inc.
Physical Medicine · 67d
Cleared May 26, 2006
EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD
K060918 · LZO
Aesculap, Inc.
Orthopedic · 52d
Cleared May 26, 2006
THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS...
K061052 · MHX
Philips Medical Systems North...
Cardiovascular · 39d
Cleared May 26, 2006
FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR
K061228 · LQZ
Bryan Keropian Dds
Dental · 24d
Cleared May 25, 2006
DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH...
K053358 · GZL
Ad-Tech Medical Instrument Corp
Neurology · 174d