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
75289–75312 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 2002
OCULIGHT SL/SLX
K020374 · HQF
Iridex Corp
Ophthalmic · 88d
Cleared May 03, 2002
THE NURTURE III BREAST PUMP
K020375 · HGX
Bailey Medical Engineering
Obstetrics & Gynecology · 88d
Cleared May 03, 2002
MASTER & FRANK SURGICAL DRAPES (STERILE)
K020393 · KKX
Master & Frank Enterprses Co., Ltd.
General Hospital · 86d
Cleared May 03, 2002
MEDION 6000
K020476 · EGJ
Selectivemed Components, Inc.
Physical Medicine · 80d
Cleared May 03, 2002
SMOKE EVACUATION HOSES/TUBING
K020510 · FYD
Dm Medical, Inc.
General Hospital · 77d
Cleared May 03, 2002
MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM
K020554 · JWJ
Kinetikos Medical, Inc.
Orthopedic · 72d
Cleared May 03, 2002
STARFLOW HV
K020760 · EBF
Danville Materials, Inc.
Dental · 57d
Cleared May 03, 2002
PULMO-MIST COMPRESSOR MODEL # 4323
K020797 · BTI
Nidek Medical Products, Inc.
Anesthesiology · 52d
Cleared May 03, 2002
ECHOSCAN, MODEL US-1800
K020876 · IYO
Nidek, Inc.
Radiology · 46d
Cleared May 03, 2002
GC ELITE CEMENT 100
K021038 · EMA
GC America, Inc.
Dental · 32d
Cleared May 03, 2002
EBI XFIX DFS SYSTEM
K021091 · KTT
Ebi, L.P.
Orthopedic · 29d
Cleared May 03, 2002
MODIFICATION TO TSRH SPINAL SYSTEM
K021106 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared May 03, 2002
ESOP HA FEMORAL STEM
K021108 · MEH
Fournitures Hospitalieres
Orthopedic · 28d
Cleared May 03, 2002
SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION...
K021216 · FPA
Sterling Medivations, Inc.
General Hospital · 16d
Cleared May 03, 2002
ACE HA SCREW DENTAL IMPLANT SYSTEM
K021244 · DZE
Ace Surgical Supply Co., Inc.
Dental · 14d
Cleared May 03, 2002
DEGOTZEN SYNCHRO
K021245 · EHD
The Gotzen Group, Inc.
Radiology · 14d
Cleared May 02, 2002
TRANSSEPTAL NEEDLE/TROCAR
K011727 · DRC
Thomas Medical Products, Inc.
Cardiovascular · 332d
Cleared May 02, 2002
TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING...
K013484 · DRF
Stereotaxis, Inc.
Cardiovascular · 195d
Cleared May 02, 2002
GIVEN DIAGNOSTIC SYSTEM
K020341 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 90d
Cleared May 02, 2002
RPX TITANIUM CEMNT RESTRICTOR
K020344 · JDK
Sulzer Spine-Tech
Orthopedic · 90d
Cleared May 02, 2002
ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING...
K020348 · JZO
Axis-Shield Diagnostics, Ltd.
Immunology · 87d
Cleared May 02, 2002
ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS
K020349 · JZO
Axis-Shield Diagnostics, Ltd.
Immunology · 87d
Cleared May 02, 2002
SYSTEM 2000 CONTROLLER, SYSTEM 5000 CONTROLLER, FOOTSWITCH, POWER CORD, AND...
K020408 · GEI
Arthrocare Corp.
General & Plastic Surgery · 84d
Cleared May 02, 2002
HIVOX EAR THERMOMETER, TS SERIES
K020471 · FLL
Hivox Biotek, Inc.
General Hospital · 79d