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
59089–59112 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 2007
DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS
K071784 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 23d
Cleared Jul 24, 2007
EYE SEE MULTIPURPOSE CONTACT LENS SOLUTION
K070767 · LPN
Lapis Lazuli International NV
Ophthalmic · 126d
Cleared Jul 24, 2007
INION BIORESTORE
K070784 · LYC
Inion OY
Dental · 125d
Cleared Jul 24, 2007
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS...
K071119 · LZA
Gx Corporation Sdn Bhd
General Hospital · 95d
Cleared Jul 24, 2007
DL900 SERIES HOLTER RECORDER
K071733 · MWJ
Braemar, Inc.
Cardiovascular · 28d
Cleared Jul 23, 2007
ONE STEP HCG PREGNANCY TEST
K062703 · LCX
Ai DE Diagnostic Co., Ltd.
Chemistry · 315d
Cleared Jul 23, 2007
UNIWEB, VERSION 5.0
K071166 · LLZ
Electronic Business Machine Co., Ltd....
Radiology · 88d
Cleared Jul 23, 2007
NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT
K071191 · FPD
Novartis Nutrition Corp.
Gastroenterology & Urology · 84d
Cleared Jul 23, 2007
CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
K071572 · DTZ
Terumo Corp.
Cardiovascular · 45d
Cleared Jul 23, 2007
IMAGIC V2.0
K071602 · LLZ
Ashva Technologies, Pvt., Ltd.
Radiology · 42d
Cleared Jul 23, 2007
TRACKLEAF-10
K071701 · IYE
Direx Systems Corp.
Radiology · 32d
Cleared Jul 23, 2007
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP -...
K071847 · MOS
Shanghai Chenguang Medical...
Radiology · 18d
Cleared Jul 20, 2007
STRYKER PEEK TWINLOOP TAC
K070882 · MBI
Stryker Endoscopy
Orthopedic · 112d
Cleared Jul 20, 2007
GSO GS1 SPINAL SYSTEM
K070966 · KWP
Gold Standard Orthopaedics, LLC
Orthopedic · 106d
Cleared Jul 20, 2007
TRIBOGLIDE LUBRICATED SILICONE-FREE SYRINGE
K071027 · FMF
Tribofilm Research, Inc.
General Hospital · 100d
Cleared Jul 20, 2007
NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM
K071147 · KWT
Nexa Orthopedics, Inc.
Orthopedic · 87d
Cleared Jul 20, 2007
ALLEGRO OCULYZER
K071183 · MXK
Wavelight AG
Ophthalmic · 81d
Cleared Jul 20, 2007
MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
K071300 · GXI
Smith & Nephew, Inc.
Neurology · 72d
Cleared Jul 20, 2007
WHEELCHAIR MODEL STS
K071390 · IPL
Innovative Products, Inc.
Physical Medicine · 63d
Cleared Jul 20, 2007
JAZZ BLOOD GLUCOSE MONITORING SYSTEM
K071393 · NBW
Agamatrix
Chemistry · 60d
Cleared Jul 20, 2007
NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003
K071714 · HAW
Orthosoft, Inc.
Neurology · 28d
Cleared Jul 20, 2007
VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207,...
K071801 · JIX
Ortho-Clinical Diagnostics, Inc.
Chemistry · 18d
Cleared Jul 19, 2007
BUSSE EPIDURAL CATHETER
K070465 · BSO
Busse Hospital Disposables, Inc.
Anesthesiology · 153d
Cleared Jul 19, 2007
MODIFICATION TO KAVO QUATTROCARE
K071288 · EBF
Sybron Dental Specialties, Inc.
Dental · 72d