FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

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175,820 results
20329–20352 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 2020
VARO Plan
K200078 · LLZ
3D Industrial Imaging Co., Ltd.
Radiology · 87d
Cleared Apr 10, 2020
Zimmer Hip Joint Replacement
K200112 · LZO
Zimmer GmbH
Orthopedic · 84d
Cleared Apr 10, 2020
OrthAlign Plus System
K200642 · OLO
Orthalign, Inc.
Orthopedic · 30d
Cleared Apr 10, 2020
ACUSON Freestyle Diagnostic Ultrasound System
K200644 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Apr 10, 2020
DR-ID 1200SDK System
K200668 · MQB
Fujifilm Corporation
Radiology · 28d
Cleared Apr 09, 2020
OxSAT 100
K191574 · DQA
S.L.P. , Ltd.
Anesthesiology · 300d
Cleared Apr 09, 2020
ATLAS Plating System
K191867 · HRS
MiRus, LLC
Orthopedic · 272d
Cleared Apr 09, 2020
Nautilus Smart ECMO Module
K191935 · BYS
Mc3 Incorporated
Cardiovascular · 265d
Cleared Apr 09, 2020
Rejuvapen NXT
K192138 · QAI
Refine USA, LLC
General & Plastic Surgery · 245d
Cleared Apr 09, 2020
Unified Arrhythmia Diagnostic System PocketECG IV
K193104 · DSI
Medicalgorithmics S.A.
Cardiovascular · 153d
Cleared Apr 09, 2020
PreXion3D Explorer EX
K193329 · OAS
Prexion Corporation
Radiology · 129d
Cleared Apr 09, 2020
ClearCalc
K193640 · MUJ
Radformation, Inc.
Radiology · 104d
Cleared Apr 09, 2020
MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus...
K200001 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 98d
Cleared Apr 09, 2020
CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC...
K200052 · ODP
Orthofix, Inc.
Orthopedic · 90d
Cleared Apr 09, 2020
Powder Free Nitrile Examination Glove (Aqua Green)
K200326 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 59d
Cleared Apr 09, 2020
i-STAT CG4+ Cartridge with the i-STAT 1 System
K200492 · CHL
Abbott Point of Care, Inc.
Chemistry · 41d
Cleared Apr 09, 2020
Standard Trocar
K200517 · GCJ
Standard Bariatrics
General & Plastic Surgery · 38d
Cleared Apr 09, 2020
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with...
K200539 · LZA
Sri Trang Gloves (Thailand) Public...
General Hospital · 37d
Cleared Apr 09, 2020
Medtronic External Drainage and Monitoring System, Medtronic External...
K200630 · GWM
Medtronic, Inc.
Neurology · 30d
Cleared Apr 09, 2020
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit
K200634 · DSP
Arrow International, Inc.
Cardiovascular · 30d
Cleared Apr 09, 2020
hyperion X5, NewTom GO, X-RADiUS COMPACT
K200688 · OAS
Cefla S.C.
Radiology · 24d
Cleared Apr 09, 2020
EchoNavigator
K200713 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 22d
Cleared Apr 08, 2020
Standard Bougie
K191885 · KNT
Standard Bariatrics
Gastroenterology & Urology · 268d
Cleared Apr 08, 2020
Panthera Dental Milled Bars
K192108 · NHA
Panthera Dental, Inc.
Dental · 247d