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
81073–81096 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 09, 2001
PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES
K003072 · DTB
Biotronik, Inc.
Cardiovascular · 98d
Cleared Jan 09, 2001
BARD MEMOTHERM ENDOSCOPIC BILIARY STENT
K003186 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 09, 2001
AUROFILM NP
K003387 · EJH
Metalor Dental USA Corp.
Dental · 70d
Cleared Jan 09, 2001
UNIGRAFT
K003457 · LYC
Unicare Biomedical
Dental · 63d
Cleared Jan 09, 2001
RAPIDD HIGHSPEED DENTAL HANDPIECE
K003518 · EFB
Dentsply Intl.
Dental · 55d
Cleared Jan 09, 2001
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K003619 · LTT
Dade Microscan, Inc.
Microbiology · 48d
Cleared Jan 09, 2001
SHANGHAI CHINA STAR CORP POWDERED BLUE NITRILE PATIENT EXAMINATION GLOVES
K003675 · LZA
Shanghai China Star Corp
General Hospital · 41d
Cleared Jan 08, 2001
KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS
K001896 · DPS
Suzuken Co., Ltd.
Cardiovascular · 201d
Cleared Jan 08, 2001
ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER
K002603 · LDF
Zcv ,Inc.
Cardiovascular · 139d
Cleared Jan 08, 2001
STERILE PISTON SYRINGE
K002717 · FMF
Abbott Laboratories
General Hospital · 130d
Cleared Jan 08, 2001
FLEXIBLE OCCLUSION SYSTEM
K002915 · DXC
Applied Medical
Cardiovascular · 112d
Cleared Jan 08, 2001
MICROPOBE SERIES OF LASERS AND ACCESSORIES
K003151 · GEX
Endooptiks, Inc.
General & Plastic Surgery · 90d
Cleared Jan 08, 2001
TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM
K003164 · HET
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 90d
Cleared Jan 08, 2001
BIO-ABSORBABLE CORKSCREW MODEL AR-1920B
K003227 · MAI
Arthrex, Inc.
Orthopedic · 84d
Cleared Jan 08, 2001
STICK NET
K003334 · EBI
Stick Tech , Ltd.
Dental · 75d
Cleared Jan 08, 2001
COLLAGEN PERIODONTAL MEMBRANE
K003339 · NPL
Collagen Matrix, Inc.
Dental · 75d
Cleared Jan 08, 2001
ISOLA CLOSED DUAL ROD CONNECTOR
K003822 · KWP
Depuyacromed
Orthopedic · 28d
Cleared Jan 08, 2001
PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION
K003827 · FMI
Bio-Plexus, Inc.
General Hospital · 28d
Cleared Jan 08, 2001
PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS
K003925 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 19d
Cleared Jan 08, 2001
INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND...
K990800 · DSY
Intervascular, Inc.
Cardiovascular · 670d
Cleared Jan 06, 2001
OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT...
K003136 · LPL
Ocular Sciences Puerto Rico, Inc.
Ophthalmic · 92d
Cleared Jan 05, 2001
KELO-COTE TOPICAL GEL
K002488 · MDA
Advanced Bio-Technologies, Inc.
General & Plastic Surgery · 144d
Cleared Jan 05, 2001
LENSOCLEAN MULTI-PURPOSE SOLUTION, MODEL 355ML
K003031 · LPN
Alpha Vista, Inc.
Ophthalmic · 99d
Cleared Jan 05, 2001
MIZAR, BASIS BE, SANDMAN DIGITAL
K003154 · GWL
Eb Neuro S.P.A.
Neurology · 87d