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
80857–80880 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 2001
ACE SDS 3.75MM SCREW DENTAL IMPLANT
K002075 · DZE
Ace Surgical Supply Co., Inc.
Dental · 207d
Cleared Feb 02, 2001
WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE
K002219 · GXY
Wandy Rubber Industrial Co., Ltd.
Neurology · 193d
Cleared Feb 02, 2001
WANDY SILICONE CONDUCTIVE RUBBER PAD
K002227 · GXY
Wandy Rubber Industrial Co., Ltd.
Neurology · 193d
Cleared Feb 02, 2001
P3IMRT TM
K002237 · MUJ
Adac Laboratories
Radiology · 193d
Cleared Feb 02, 2001
EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER
K002407 · JGS
Medica Corp.
Chemistry · 179d
Cleared Feb 02, 2001
SELECT SEED I-125
K002429 · KXK
Nucletron Corp.
Radiology · 178d
Cleared Feb 02, 2001
SURGI-VISION GUIDEWIRE COIL
K003436 · MOS
Surgi-Vision, Inc.
Radiology · 88d
Cleared Feb 02, 2001
ODYSSEY LX, MODEL 211320
K003437 · LLZ
Philips Medical Systems (Cleveland),...
Radiology · 88d
Cleared Feb 02, 2001
NEXT GENERAL M20 SURGICAL LIGHT
K003489 · FSS
Medical Illumination International, Inc.
General & Plastic Surgery · 81d
Cleared Feb 02, 2001
PORTALVISION
K003636 · IYE
Varian Medical Systems, Inc.
Radiology · 70d
Cleared Feb 02, 2001
PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
K003655 · MOS
Mri Devices Corp.
Radiology · 67d
Cleared Feb 02, 2001
DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048
K003710 · FET
Smith & Nephew, Inc.
Gastroenterology & Urology · 63d
Cleared Feb 02, 2001
CLEAN SCRAPE
K003773 · GEI
Webb Research Ii, Inc.
General & Plastic Surgery · 58d
Cleared Feb 02, 2001
OPDIMA
K003945 · IZH
Siemens Medical Solutions USA, Inc.
Radiology · 43d
Cleared Feb 02, 2001
X-RAY SYSTEM XR-MX
K004037 · JAA
Karl Storz Endoscopy
Radiology · 36d
Cleared Feb 02, 2001
MODIFICATION TO ARTOSCAN M
K010057 · LNH
Biosound Esaote, Inc.
Radiology · 25d
Cleared Feb 02, 2001
ANALGESIC PULSER, MODEL AP-439
K993229 · GZJ
Johari Electro-Tech Co.
Neurology · 494d
Cleared Feb 01, 2001
TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018
K002042 · HGI
New England Medical Corp.
Obstetrics & Gynecology · 211d
Cleared Feb 01, 2001
PERSONAL GLUCOSE CONTROL CHARTING SYSTEM
K002688 · CGA
Lxn Corp.
Chemistry · 156d
Cleared Feb 01, 2001
CLIRANS E-SERIES HOLLOW FIBER DIALYZERS
K003425 · KDI
Terumo Medical Corp.
Gastroenterology & Urology · 90d
Cleared Feb 01, 2001
SUCTION IRRIGATOR
K003443 · FHF
Applied Medical
Gastroenterology & Urology · 87d
Cleared Feb 01, 2001
BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
K003461 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 86d
Cleared Feb 01, 2001
PROCLUDE-SENSITIVE
K003482 · LBH
Ortek Therapeutics, Inc.
Dental · 84d
Cleared Feb 01, 2001
STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS
K003615 · FKP
Environmental Test Systems, Inc.
Gastroenterology & Urology · 71d