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
13609–13632 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 10, 2022
Overjet Caries Assist
K212519 · MYN
Overjet, Inc.
Radiology · 273d
Cleared May 10, 2022
Needle Free Connector
K213004 · FPA
Medcaptain Life Science Co., Ltd.
General Hospital · 232d
Cleared May 10, 2022
Dental diode laser
K214008 · NVK
Shenzhen Soga Technology Co., Ltd.
Dental · 139d
Cleared May 10, 2022
White Nitrile Powder-Free Patient Examination Glove, Non Sterile
K220427 · LZA
One Glove Industrial Sdn Bhd
General Hospital · 84d
Cleared May 10, 2022
Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile
K220428 · LZA
One Glove Industrial Sdn Bhd
General Hospital · 84d
Cleared May 10, 2022
SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System
K220711 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 60d
Cleared May 10, 2022
inHEART MODELS
K220727 · LLZ
Inheart, Sas
Radiology · 57d
Cleared May 10, 2022
Identity Imprint Knee Replacement System (including Identity Imprint...
K221059 · JWH
Conformis, Inc.
Orthopedic · 29d
Cleared May 10, 2022
RadiForce MX243W
K221136 · PGY
Eizo Corporation
Radiology · 21d
Cleared May 09, 2022
Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
K203429 · NJR
Cepheid
Microbiology · 535d
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 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