FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
79945–79968 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 11, 2001
NUMED GHOST II PTA CATHETERS
K003972 · LIT
NuMED, Inc.
Cardiovascular · 20d
Cleared Jan 10, 2001
TRIAD II MODULAR TOTAL HIP SYSTEM
K003199 · LPH
Osteoimplant Technology, Inc.
Orthopedic · 90d
Cleared Jan 10, 2001
FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II
K003202 · GEX
Altus Medical
General & Plastic Surgery · 90d
Cleared Jan 10, 2001
U2 HIP STEM, TI POROUS COATED
K003237 · LPH
United Orthopedic Corp.
Orthopedic · 85d
Cleared Jan 10, 2001
BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G,...
K003603 · EJT
Jelenko Co.
Dental · 50d
Cleared Jan 09, 2001
SYNTHES (USA) RESORBABLE TACK SYSTEM
K000560 · JEY
Synthes (Usa)
Dental · 326d
Cleared Jan 09, 2001
VENODYNE DVT ADVANTAGE MODEL 610
K001802 · JOW
Microtek Medical, Inc.
Cardiovascular · 209d
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