FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
19729–19752 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 2020
AcuityPDR
K200726 · IZL
Radmedix, LLC
Radiology · 24d
Cleared Apr 12, 2020
VERASENSE for Stryker Triathlon
K200665 · ONN
Orthosensor, Inc.
Orthopedic · 30d
Cleared Apr 11, 2020
Nerve and Muscle Stimulator
K193275 · IPF
Shenzhen Xft Medical Limited
Physical Medicine · 137d
Cleared Apr 10, 2020
Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac
K190353 · PLC
Residential Home Sleep Services
Dental · 420d
Cleared Apr 10, 2020
Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single...
K192679 · MEG
Gemtier Medical (Shanghai), Inc.
General Hospital · 197d
Cleared Apr 10, 2020
Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition...
K193215 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 141d
Cleared Apr 10, 2020
SIGNA Premier
K193282 · LNH
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 135d
Cleared Apr 10, 2020
Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI...
K193573 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 109d
Cleared Apr 10, 2020
SkinStylus SteriLock MicroSystem
K200044 · QAI
Esthetic Education, LLC
General & Plastic Surgery · 93d
Cleared Apr 10, 2020
KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with...
K200072 · LZA
Kimberly Clark Corporation
General Hospital · 87d
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