Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
76417–76440 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 02, 2002
AKUPORT M1
K020567 · GZO
Vibrant Health
Neurology · 71d
Cleared May 02, 2002
DUOPRO SAFETY SYRINGE (DUOPROSS)
K020623 · MEG
M.K. Meditech Co. , Ltd.
General Hospital · 65d
Cleared May 02, 2002
DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300
K020687 · JZO
Axis-Shield Diagnostics, Ltd.
Immunology · 59d
Cleared May 02, 2002
SYNTEX POWDER-FREE POLYMER-COATED NITRILE EXAMINATION GLOVE
K020751 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 56d
Cleared May 02, 2002
VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596
K020752 · MID
Pharmacia Deutschland GmbH
Immunology · 56d
Cleared May 02, 2002
VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796
K020757 · MID
Pharmacia Deutschland GmbH
Immunology · 56d
Cleared May 02, 2002
VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696
K020758 · MID
Pharmacia Deutschland GmbH
Immunology · 56d