FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
82057–82080 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 07, 2000
SULZER ORTHOPEDICS INC. NATURAL-HIP SYSTEM LD STEM
K001320 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 72d
Cleared Jul 07, 2000
CARDEON ASCENDING BALLOON CANNULA (ABC)
K001371 · DWF
Cardeon Corp.
Cardiovascular · 67d
Cleared Jul 07, 2000
MODIFICATION TO PROMPT L-POP
K001494 · KLE
Espe Dental AG
Dental · 56d
Cleared Jul 07, 2000
DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM
K001707 · LGD
Diamedix Corp.
Microbiology · 32d
Cleared Jul 07, 2000
POROCOAT PRODIGY HIP PROSTHESIS
K001778 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 24d
Cleared Jul 07, 2000
THE V-BAG
K001822 · DTN
Circulatory Technology, Inc.
Cardiovascular · 21d
Cleared Jul 07, 2000
IM-9C MICROINJECTORS
K001910 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 14d
Cleared Jul 07, 2000
IM-9A MICROINJECTORS
K001911 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 14d
Cleared Jul 07, 2000
IM-9B MICROINJECTORS
K001912 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 14d
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