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
81553–81576 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 07, 2000
FLUORO-TEX CARDIOVASCULAR PATCH
K994032 · DXZ
Bridger Biomed, Inc.
Cardiovascular · 224d
Cleared Jul 06, 2000
PROLONG, MODELS PL50, PL100, PL150
K001129 · CAZ
Life-Tech Intl., Inc.
Anesthesiology · 90d
Cleared Jul 06, 2000
HITACHI AIRIS II
K001334 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 70d
Cleared Jul 06, 2000
LIFERX
K001596 · LLZ
Bowdengs Technologies, LLC
Radiology · 44d
Cleared Jul 06, 2000
LUNAR REPORT GENERATOR II
K001756 · KGI
Lunar Corp.
Radiology · 27d
Cleared Jul 06, 2000
LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA
K001772 · HQF
Taracan Pty. , Ltd.
Ophthalmic · 24d
Cleared Jul 06, 2000
SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
K001789 · OXD
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 23d
Cleared Jul 06, 2000
MODIFICATION TO E-SCAN
K001894 · LNH
Biosound Esaote, Inc.
Radiology · 15d
Cleared Jul 06, 2000
LOOP ELECTRODE, BALL ELECTRODE
K993527 · HGI
Palm Medical USA, Inc.
Obstetrics & Gynecology · 262d
Cleared Jul 06, 2000
MEDISANA DIGITAL TENS
K994265 · GZJ
Fuji Dynamics Limited
Neurology · 202d
Cleared Jul 06, 2000
FDTENS 2010
K994266 · GZJ
Fuji Dynamics Limited
Neurology · 202d
Cleared Jul 05, 2000
KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD...
K000901 · FYA
Molnlycke Health Care, Inc.
General Hospital · 106d
Cleared Jul 05, 2000
CRYSTAL-EEG MODEL 15
K001110 · OMC
Cleveland Medical Devices, Inc.
Neurology · 90d
Cleared Jul 05, 2000
COMFORT STIM
K001117 · GXY
R & D Medical Products, Inc.
Neurology · 90d
Cleared Jul 05, 2000
AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)
K001137 · CAF
Trudell Medical Int'L
Anesthesiology · 86d
Cleared Jul 05, 2000
POLYMER COATED POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K001165 · LYY
Medipure Corporation (M) Sdn. Bhd.
General Hospital · 86d
Cleared Jul 05, 2000
CORRECT PLUS
K001218 · ELW
Jeneric/Pentron, Inc.
Dental · 79d
Cleared Jul 05, 2000
DANIELS SHARPSMART REUSABLE SHARPS CONTAINER
K001337 · MMK
The Daniels Corp.
General Hospital · 69d
Cleared Jul 05, 2000
SUPREMCAST V
K001383 · EJH
American Dent-All, Inc.
Dental · 64d
Cleared Jul 05, 2000
ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S
K001418 · EIH
Procera Sandvik, Inc.
Dental · 61d
Cleared Jul 05, 2000
RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000
K001430 · BTL
Vortran Medical Technology 1, Inc.
Anesthesiology · 61d
Cleared Jul 05, 2000
DISPOSABLE PVC SYNTHETIC EXAM GLOVES, POWDER FREE
K001432 · LYZ
Shanghai PM Plastics Ent. Co., Ltd.
General Hospital · 58d
Cleared Jul 05, 2000
R&D PROJECT DW269#25
K001469 · EJS
Ivoclar North America, Inc.
Dental · 56d
Cleared Jul 05, 2000
GRADIA
K001518 · EBF
GC America, Inc.
Dental · 50d