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
20521–20544 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 2020
CPT Hip System
K191735 · JDI
Zimmer, Inc.
Orthopedic · 266d
Cleared Mar 20, 2020
Clearform Aligners
K191838 · NXC
Motor City Lab Works
Dental · 255d
Cleared Mar 20, 2020
EnlightenVue Microendoscopy System
K192300 · GCJ
Enlightenvue, Inc.
General & Plastic Surgery · 210d
Cleared Mar 20, 2020
DIAFIL & DIAFIL Capsule
K192510 · EBF
DiaDent Group International
Dental · 190d
Cleared Mar 20, 2020
icotec Cervical Cage
K192897 · ODP
Icotec AG
Orthopedic · 161d
Cleared Mar 20, 2020
MULTIX Impact
K193089 · KPR
Siemens Medical Solutions USA, Inc.
Radiology · 135d
Cleared Mar 20, 2020
GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim...
K193121 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 129d
Cleared Mar 20, 2020
ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter
K193183 · OBJ
Acist Medical Systems, Inc.
Cardiovascular · 123d
Cleared Mar 20, 2020
Nano FortiFix® System
K193211 · NKB
Nanovis Spine, LLC
Orthopedic · 120d
Cleared Mar 20, 2020
Hepatic VCAR
K193281 · JAK
GE Medical Systems SCS
Radiology · 114d
Cleared Mar 20, 2020
Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health...
K193327 · FYA
Cardinal Health200, LLC
General Hospital · 109d
Cleared Mar 20, 2020
T2 ICF
K193366 · HWC
Stryker GmbH
Orthopedic · 107d
Cleared Mar 20, 2020
Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder...
K193560 · QHE
Materialise NV
Orthopedic · 88d
Cleared Mar 20, 2020
Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy...
K193581 · LZA
Sri Trang Gloves (Thailand) Public...
General Hospital · 88d
Cleared Mar 20, 2020
Q Switched Nd: YAG Laser machine
K193609 · GEX
Beijing Lead Beauty S & T Co., Ltd.
General & Plastic Surgery · 85d
Cleared Mar 20, 2020
iTero Element 5D
K193659 · NTK
Align Technology, Inc.
Dental · 81d
Cleared Mar 20, 2020
AI-ECG Tracker
K200036 · DPS
Shenzhen Carewell Electronics Co., Ltd.
Cardiovascular · 72d
Cleared Mar 20, 2020
MTS Omadacycline 0.002 - 32 ug/mL
K200180 · JWY
Liofilchem S. R. L.
Microbiology · 56d
Cleared Mar 20, 2020
Symbia 6.7
K200474 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 23d
Cleared Mar 19, 2020
Park's Pectus System
K191057 · HRS
Tdm Co., Ltd.
Orthopedic · 332d
Cleared Mar 19, 2020
IV Sets not made with PVC
K191658 · FPA
B.Braun Medical, Inc.
General Hospital · 272d
Cleared Mar 19, 2020
F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)
K191818 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 258d
Cleared Mar 19, 2020
Compression Therapy Device
K191856 · JOW
Guangzhou Longest Science &...
Cardiovascular · 252d
Cleared Mar 19, 2020
Creo Electrosurgical System with HS1 Hemostasis Accessory
K192905 · KNS
Creo Medical, Ltd.
Gastroenterology & Urology · 156d