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
71761–71784 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 2003
EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170
K030974 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 28d
Cleared Apr 25, 2003
EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210
K030975 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 28d
Cleared Apr 25, 2003
TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR...
K030983 · MSD
Deltec, Inc.
Gastroenterology & Urology · 28d
Cleared Apr 24, 2003
ELOX P 45-BP
K023205 · DTB
Biotronik, Inc.
Cardiovascular · 211d
Cleared Apr 24, 2003
APPLANATION TONOMETER
K023676 · HKX
Optilasa, S.L.
Ophthalmic · 174d
Cleared Apr 24, 2003
AMATOMICAL SHOULDER WITH REMOVABLE HEAD
K030259 · KWS
Centerplus Orthopedics, Inc.
Orthopedic · 90d
Cleared Apr 24, 2003
BATTERY, RECHARGEABLE
K030261 · HGM
Access Battery, Inc.
Obstetrics & Gynecology · 90d
Cleared Apr 24, 2003
IMPACT SUTURE ANCHOR. MODEL 433510
K030388 · HWC
Bionx Implants, Ltd.
Orthopedic · 78d
Cleared Apr 24, 2003
C. DIFFICILE TOX A/B II
K030404 · LLH
Techlab, Inc.
Microbiology · 77d
Cleared Apr 24, 2003
A127 LEAD EXTENSION
K030461 · GZB
Advanced Neuromodulation Systems
Neurology · 71d
Cleared Apr 24, 2003
HL888JF
K030541 · DXN
Health & Life Co., Ltd.
Cardiovascular · 63d
Cleared Apr 24, 2003
RADII
K030568 · EBZ
Southern Dental Industries, Inc.
Dental · 59d
Cleared Apr 24, 2003
BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM
K030595 · KWQ
Blackstone Medical, Inc.
Orthopedic · 58d
Cleared Apr 24, 2003
QUANTA PLEX ENA PROFILE 5
K030681 · LLL
Inova Diagnostics, Inc.
Immunology · 50d
Cleared Apr 24, 2003
SAFFRON NM GUIDING CATHETER
K030715 · DQY
Neich Medical (Shenzhen) Company Limited
Cardiovascular · 48d
Cleared Apr 24, 2003
Z-BOX
K030764 · HAW
Z-Kat, Inc.
Neurology · 44d
Cleared Apr 24, 2003
5F MEDTRONIC LAUNCHER GUIDE CATHETER
K030779 · DQY
Medtronic Vascular
Cardiovascular · 44d
Cleared Apr 24, 2003
VERITAS COLLAGEN MATRIX
K030879 · OXE
Synovis Surgical Innovations
General & Plastic Surgery · 35d
Cleared Apr 24, 2003
MODIFICATION TO MODULAR PLUS REVISION STEM
K030971 · LWJ
Plus Orthopedics
Orthopedic · 27d
Cleared Apr 24, 2003
MODIFICATION TO DEPUY SOLUTION SYSTEM HIP PROSTHESIS
K030979 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Apr 24, 2003
SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14,...
K030984 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 27d
Cleared Apr 24, 2003
EDWARDS INTRODUCER SHEATH
K031087 · DYB
Edwards Lifesciences, LLC
Cardiovascular · 17d
Cleared Apr 24, 2003
MODIFICATION TO XIA STAINLESS STEEL SYSTEM
K031090 · KWP
Howmedica Osteonics Corp.
Orthopedic · 17d
Cleared Apr 23, 2003
PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD...
K023256 · NBW
Abbott Laboratories
Chemistry · 205d