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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
36409–36432 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 2014
ORTHOFIX GALAXY WRIST
K141760 · KTT
Orthofix Srl
Orthopedic · 160d
Cleared Dec 08, 2014
BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500
K141795 · MKJ
R & D Batteries, Inc.
Cardiovascular · 158d
Cleared Dec 08, 2014
Valeo C Spacer System, Valeo II C IBF Device
K142264 · ODP
Amedica Corp.
Orthopedic · 115d
Cleared Dec 08, 2014
Hospira Extension Set
K142433 · FPA
Hospira, Inc.
General Hospital · 101d
Cleared Dec 05, 2014
PESSARY
K132313 · HHW
Eis Corporation
Obstetrics & Gynecology · 498d
Cleared Dec 05, 2014
NAVIGABLE BRAIN BIOPSY CANNULA SET
K140705 · HAW
Izi Medical Products
Neurology · 259d
Cleared Dec 05, 2014
IV ADMINISTRATION SET WITH HAND PUMP
K140838 · FPA
B.Braun Medical, Inc.
General Hospital · 247d
Cleared Dec 05, 2014
CARDIOSPY ECG HOLTER SYSTEMS
K140847 · MLO
Labtech Kft.
Cardiovascular · 246d
Cleared Dec 05, 2014
IGROW II HAIR GROWTH SYSTEM
K140931 · OAP
Apira Science, Inc.
General & Plastic Surgery · 238d
Cleared Dec 05, 2014
LYTHOS DIGITAL IMPRESSION SYSTEM
K141611 · NOF
Ormco Corp.
Dental · 172d
Cleared Dec 05, 2014
SYSMEX XN SERIES
K141681 · GKZ
Sysmex America, Inc.
Hematology · 165d
Cleared Dec 05, 2014
I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE]
K141701 · KXK
Isoaid, LLC
Radiology · 164d
Cleared Dec 05, 2014
XN CAL PF
K141955 · KRX
Streck
Hematology · 140d
Cleared Dec 05, 2014
XN CHECK BF
K141957 · JPK
Streck
Hematology · 140d
Cleared Dec 05, 2014
XN CAL
K141962 · KRX
Streck
Hematology · 140d
Cleared Dec 05, 2014
XN CHECK
K141964 · JPK
Streck
Hematology · 140d
Cleared Dec 05, 2014
ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT
K142052 · KTT
Orthofix Srl
Orthopedic · 130d
Cleared Dec 05, 2014
QUALITY REPORTS
K142142 · IYE
Sun Nuclear Corporation
Radiology · 122d
Cleared Dec 05, 2014
Discovery MR750 3.0T
K142361 · LNH
Ge Medical Systems, LLC
Radiology · 102d
Cleared Dec 05, 2014
Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack
K142365 · OCC
Focus Diagnostics
Microbiology · 102d
Cleared Dec 05, 2014
Passeo-35 PTA Catheter
K142379 · LIT
Biotronik, Inc.
Cardiovascular · 101d
Cleared Dec 05, 2014
Neo Total Knee System
K142388 · JWH
New Era Orthopedics, LLC
Orthopedic · 100d
Cleared Dec 05, 2014
Vinyl Co-Polymer Powder Free Examination Gloves
K142409 · LYZ
Grand Work Plastic Products Co., Ltd.
General Hospital · 100d
Cleared Dec 05, 2014
WaterProof PROFILER
K142431 · IYE
Sun Nuclear Corporation
Radiology · 98d