FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
13753–13776 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 2022
CAPRI Corpectomy Cage System
K211320 · PLR
K2m, Inc.
Orthopedic · 300d
Cleared Feb 24, 2022
uLab Systems Dental Aligner Kit
K211510 · NXC
Ulab Systems, Inc.
Dental · 286d
Cleared Feb 24, 2022
Epione
K211645 · JAK
Quantum Surgical Sas
Radiology · 272d
Cleared Feb 24, 2022
Cleaner Plus Thrombectomy System
K211798 · QEW
Argon Medical Devices, Inc.
Cardiovascular · 259d
Cleared Feb 24, 2022
Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with...
K212949 · MEG
Henan Nursecare Biotechnology Co., Ltd.
General Hospital · 161d
Cleared Feb 24, 2022
Annalise Enterprise CXR Triage Pneumothorax
K213941 · QFM
Annalise-Ai
Radiology · 70d
Cleared Feb 24, 2022
ROKI Surgical Mask
K214094 · FXX
Roki Co., Ltd.
General Hospital · 58d
Cleared Feb 24, 2022
Luminice
K214100 · NFO
Premier North America, Inc.
Neurology · 57d
Cleared Feb 24, 2022
NightOwl
K220028 · MNR
Ectosense NV
Anesthesiology · 50d
Cleared Feb 24, 2022
ArtiSential Laparoscopic Instruments-Electrodes
K220384 · GEI
Livsmed, Inc.
General & Plastic Surgery · 14d
Cleared Feb 23, 2022
StimRouter Neuromodulation System
K211965 · GZF
Bioness, Inc.
Neurology · 244d
Cleared Feb 23, 2022
Arsenal Ankle Plating System
K212378 · HRS
Trilliant Surgical
Orthopedic · 205d
Cleared Feb 23, 2022
Sclerotherapy Needle
K212668 · FBK
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 184d
Cleared Feb 23, 2022
LevaLap Laparoscopic Access Device
K212786 · HIF
Core Access Surgical Technologies, Inc.
Obstetrics & Gynecology · 175d
Cleared Feb 23, 2022
SuperLine
K213599 · DZE
Dentium Co., Ltd.
Dental · 100d
Cleared Feb 23, 2022
NuVasive Reline Cervical System
K213654 · NKG
Nu Vasive, Incorporated
Orthopedic · 96d
Cleared Feb 23, 2022
Glidewell Appliance Resin, Hard/Soft
K214102 · MQC
Prismatik Dentalcraft, Inc.
Dental · 56d
Cleared Feb 23, 2022
EzOrtho v1.3
K220003 · LLZ
Ewoosoft Co., Ltd.
Radiology · 50d
Cleared Feb 23, 2022
Trigon HA Wedge Fixation System
K220197 · PLF
Nvision Biomedical Technologies, Inc.
Orthopedic · 30d
Cleared Feb 22, 2022
Flexible Video-Choledo-Cysto-Ureteroscope System
K211686 · FGB
Shanghai SeeGen Photoelectric...
Gastroenterology & Urology · 265d
Cleared Feb 22, 2022
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical...
K212380 · NEW
Ethicon, Inc.
General & Plastic Surgery · 204d
Cleared Feb 22, 2022
INLIANT Surgical Navigation System
K213392 · PLV
Navigate Surgical Technologies, Inc.
Dental · 130d
Cleared Feb 22, 2022
Enbio S
K213991 · FLE
Enbio Group AG
General Hospital · 63d
Cleared Feb 22, 2022
VALO X, VALO X Accessory Lenses
K220471 · EBZ
Ultradent Products, Inc.
Dental · 4d