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
34729–34752 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 2015
LiverMultiScan
K143020 · LNH
Mirada Medical, Ltd.
Radiology · 246d
Cleared Jun 23, 2015
Flowtron ACS900
K143438 · JOW
Getinge (Suzhou) Co., Ltd.
Cardiovascular · 203d
Cleared Jun 23, 2015
Digi-One
K143476 · IYN
Rimed , Ltd.
Radiology · 200d
Cleared Jun 23, 2015
iNSIGHT Color Doppler Ultrasound System
K150002 · IYN
Saset (Chengdu), Inc.
Radiology · 172d
Cleared Jun 23, 2015
Fill-Up!
K150218 · EBF
Coltene/Whaledent AG
Dental · 144d
Cleared Jun 23, 2015
Jade 37% Phosphoric Acid Etchant Gel
K150696 · KLE
Dharma Research, Inc.
Dental · 97d
Cleared Jun 23, 2015
Progressive Orthopaedic Total Knee System
K150783 · JWH
The Progressive Orthopaedic Company, LLC
Orthopedic · 90d
Cleared Jun 23, 2015
Dental Bone Cutting Instruments
K150796 · DZJ
Synthes USA Products, LLC
Dental · 89d
Cleared Jun 23, 2015
Solana GAS Assay, Solana instrument
K150868 · PGX
Quidel Corporation
Microbiology · 83d
Cleared Jun 23, 2015
SMV Scientific Bone Screws
K150981 · HWC
Smv Scientific
Orthopedic · 70d
Cleared Jun 23, 2015
ASAHI Corsair Microcatheter
K151103 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 60d
Cleared Jun 23, 2015
syngo.via MI Workflows
K151192 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 50d
Cleared Jun 23, 2015
Kubtec DIGIVIEW 395
K151221 · MQB
Kub Technologies, Inc.
Radiology · 47d
Cleared Jun 23, 2015
Henschke Titanium Applicator Set
K151272 · JAQ
Nucletron B.V.
Radiology · 41d
Cleared Jun 23, 2015
GF50A
K151419 · KPR
Samsung Electronics Co., Ltd.
Radiology · 26d
Cleared Jun 22, 2015
SURGICAL FACE MASK (Ear Loops and Tie-on)
K133070 · FXX
Bh Medical Products Co., Ltd.
General Hospital · 630d
Cleared Jun 22, 2015
VISCO SOFT CONTACT LENS
K141348 · LPL
Visco Vision, Inc.
Ophthalmic · 396d
Cleared Jun 22, 2015
Instru-Safe Instrument Protection System
K150540 · KCT
Summit Medical, Inc.
General Hospital · 111d
Cleared Jun 22, 2015
uNion Cervical Plate System
K150666 · KWQ
Ulrich Medical USA
Orthopedic · 98d
Cleared Jun 22, 2015
LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH...
K150879 · CEW
DiaSorin, Inc.
Chemistry · 82d
Cleared Jun 19, 2015
NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE
K133995 · OLT
Neurosoft , Ltd.
Neurology · 540d
Cleared Jun 19, 2015
ZIO SR ECG Monitoring Service
K143513 · DSH
iRhythm Technologies, Inc.
Cardiovascular · 190d
Cleared Jun 19, 2015
Propeller Model 2014-D Sensor
K143671 · CAF
Reciprocal Labs
Anesthesiology · 178d
Cleared Jun 19, 2015
XLR8 PLUS (XLR8+)
K143726 · OMP
Genadyne Biotechnologies, Inc.
General & Plastic Surgery · 172d