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
14209–14232 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 2022
Immunalysis Tapentadol Urine HEIA
K203527 · DJG
Lmmunalysis Corporation
Toxicology · 523d
Cleared May 09, 2022
Sight OLO
K211840 · GKZ
S.D. Sight Diagnostics , Ltd.
Hematology · 329d
Cleared May 09, 2022
CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy...
K213022 · EBW
Cefla S.C.
Dental · 231d
Cleared May 09, 2022
Compass BDS Biliary Stent
K213946 · FGE
Cook Ireland, Ltd.
Gastroenterology & Urology · 143d
Cleared May 09, 2022
VersaCross Connect Transseptal Dilator
K220414 · DYB
Baylis Medical Company, Inc.
Cardiovascular · 84d
Cleared May 06, 2022
IWL2020 Blood Glucose Monitoring System
K203711 · NBW
Roche Diabetes Care, Inc.
Chemistry · 501d
Cleared May 06, 2022
Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon /...
K211021 · FGE
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 396d
Cleared May 06, 2022
Elecsys Testosterone II
K211685 · CDZ
Roche Diagnostics
Chemistry · 338d
Cleared May 06, 2022
Segment 3DPrint
K211966 · LLZ
Medviso AB
Radiology · 316d
Cleared May 06, 2022
Portable Folding Electric Wheelchair (Model: DC01)
K212092 · ITI
Anhui Jbh Medical Apparatus Co., Ltd.
Physical Medicine · 304d
Cleared May 06, 2022
NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar...
K212289 · QCI
Neuronetics, Inc.
Neurology · 289d
Cleared CT May 06, 2022
Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft...
K212555 · DQA
Covidien, LLC
Anesthesiology · 266d
Cleared May 06, 2022
Electric Breast Pump
K212564 · HGX
Guangdong Horigen Mother & Baby...
Obstetrics & Gynecology · 266d
Cleared May 06, 2022
SpyGlass Discover Balloon Dilation Catheter
K212582 · GCA
Boston Scientific Corporation
Gastroenterology & Urology · 263d
Cleared May 06, 2022
Quantum Heater-Cooler
K212657 · DWC
Spectrum Medical , Ltd.
Cardiovascular · 256d
Cleared May 06, 2022
TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)
K213788 · NUH
Dongguan Bohuikang Technology Co.,Ltd
Neurology · 151d
Cleared May 06, 2022
Disposable EEG cable
K213884 · GXY
Shenzhen Changke Connect Electronics...
Neurology · 144d
Cleared May 06, 2022
WAVi SCAN EEG System and Accessories
K213900 · GWQ
Wavi Co.
Neurology · 143d
Cleared May 06, 2022
PISCES-SA Standalone ALIF Interbody System
K213935 · OVD
Osseus Fusion Systems
Orthopedic · 141d
Cleared May 06, 2022
KEOPS Balance Analyzer 3D
K213975 · LLZ
S.M.A.I.O
Radiology · 137d
Cleared CT May 06, 2022
Masimo O3 Regional Oximeter System
K214072 · MUD
Masimo Corporation
General & Plastic Surgery · 130d
Cleared May 06, 2022
Medline Orbis Chemo Surgical Gown
K214108 · FYA
Medline Industries, LP
General Hospital · 128d
Cleared May 06, 2022
Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia...
K220110 · DTR
Qura S.R.L
Cardiovascular · 113d
Cleared May 06, 2022
HM70 EVO Diagnostic Ultrasound System
K220269 · IYN
Samsung Medison Co., Ltd.
Radiology · 95d