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

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175,820 results
50761–50784 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 2010
COBAS U411 TEST SYSTEM
K093555 · KQO
Roche Diagnostics
Chemistry · 136d
Cleared Apr 02, 2010
PROXISCAN MODEL 101
K093706 · IYX
Hybridyne Imaging Technologies, Inc.
Radiology · 122d
Cleared Apr 02, 2010
PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A
K093858 · DSA
St. Jude Medical, Cardiac Rhythm...
Cardiovascular · 107d
Cleared Apr 02, 2010
ALEXIS ORTHOPAEDIC WOUND RETRACTOR
K100120 · KGW
Applied Medical Resources Corp.
General & Plastic Surgery · 77d
Cleared Apr 02, 2010
SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V
K100230 · NUV
Eleme Medical, Inc.
General & Plastic Surgery · 66d
Cleared Apr 01, 2010
MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED
K092391 · MKJ
Concord Medical Products
Cardiovascular · 239d
Cleared Apr 01, 2010
MACH LED SC
K093009 · FSY
Dr. Mach GmbH & Co. KG
General & Plastic Surgery · 184d
Cleared Apr 01, 2010
MACH LED MC
K093010 · FSY
Dr. Mach GmbH & Co. KG
General & Plastic Surgery · 184d
Cleared Apr 01, 2010
PADCHECK
K093205 · DXN
Padtest, LLC
Cardiovascular · 170d
Cleared Apr 01, 2010
1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2
K093400 · FMF
Unilife Medical Solutions Limited
General Hospital · 150d
Cleared Apr 01, 2010
CLEVER CHOICE AUTO-CODE PRO BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4267
K093506 · CGA
Taidoc Technology Corporation
Chemistry · 140d
Cleared Apr 01, 2010
SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHOR
K093844 · MAI
Smith & Nephew, Inc.
Orthopedic · 107d
Cleared Apr 01, 2010
SE-601 SERIES ELECTROCARDIOGRAPH
K093869 · DPS
Edan Instruments, Inc.
Cardiovascular · 105d
Cleared Apr 01, 2010
ELECSYS TROPONIN I CALCHECK 5
K100594 · JJX
Roche Diagnostics
Chemistry · 30d
Cleared Apr 01, 2010
INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016
K100633 · OAT
D B Orthodontics, Ltd.
Dental · 27d
Cleared Mar 31, 2010
HANDHELD ECG MONITOR, MODEL MD100
K093872 · DPS
Beijing Choice Electronic Technololgy...
Cardiovascular · 104d
Cleared Mar 31, 2010
IMNS MEDACTA NAVIGATION SYSTEM,33.221000US
K100314 · HAW
Medacta International S.A.
Neurology · 55d
Cleared Mar 31, 2010
LDR SPINE USA SPINE TUNE TL SPINE SYSTEM
K100575 · MNI
Ldr Spine USA
Orthopedic · 30d
Cleared Mar 30, 2010
SYSMEX MODEL XT-4000I
K091313 · GKZ
Sysmex America, Inc.
Hematology · 330d
Cleared Mar 30, 2010
HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2
K092448 · GZJ
Hivox Biotek, Inc.
Neurology · 232d
Cleared Mar 30, 2010
BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER
K092849 · CEM
Epocal, Inc.
Chemistry · 195d
Cleared Mar 30, 2010
VITAL SIGNS MONITOR
K093016 · DQA
Shenzhen Creative Industry Co., Ltd.
Anesthesiology · 182d
Cleared Mar 30, 2010
LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM
K093494 · OEW
Pathfinder Therapeutics, Inc.
General & Plastic Surgery · 140d
Cleared Mar 30, 2010
INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE
K093633 · CBK
Draegerwerk AG & CO Kgaa
Anesthesiology · 127d