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
15793–15816 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 2021
Auxein Nailing System
K210792 · HWC
Auxein Medical Private Limited
Orthopedic · 163d
Cleared Aug 25, 2021
PROWLER SELECT PLUS
K210838 · KRA
Medos International SARL
Neurology · 156d
Cleared Aug 25, 2021
Elvie Stride
K210936 · HGX
Chiaro Technology Limited
Obstetrics & Gynecology · 149d
Cleared Aug 25, 2021
SCAR 3
K211362 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 114d
Cleared Aug 25, 2021
CellFX System
K211444 · GEI
Pulse Biosciences, Inc.
General & Plastic Surgery · 107d
Cleared Aug 25, 2021
Disposable Surgical Mask (non sterile)
K211451 · FXX
Qinhuangdao Taizhi Medical Technology...
General Hospital · 107d
Cleared Aug 25, 2021
AMSCO 600 Medium Steam Sterilizer
K211500 · FLE
STERIS Corporation
General Hospital · 103d
Cleared Aug 25, 2021
ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert
K211609 · JWH
Depuy Ireland UC
Orthopedic · 92d
Cleared Aug 25, 2021
ExcelsiusHub
K211616 · OLO
Globus Medical, Inc.
Orthopedic · 91d
Cleared Aug 25, 2021
RFA-1717DIG, RFA-1717DIC
K212051 · MQB
Astel, Inc.
Radiology · 56d
Cleared Aug 25, 2021
Diagnostic X-ray System/PLX5200A
K212134 · IZL
Nanjing Perlove Medical Equipment...
Radiology · 48d
Cleared Aug 25, 2021
Instinct Plus Endoscopic Clipping Device
K212323 · PKL
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 30d
Cleared Aug 24, 2021
Prime BIOFOAM® Multi-Hole Shells
K201157 · MBL
Microport Orthopedics, Inc.
Orthopedic · 481d
Cleared Aug 24, 2021
ELAN 4 Electro Motor System
K203739 · HBE
Aesculap, Inc.
Neurology · 245d
Cleared Aug 24, 2021
Auto Disable Syringe
K210464 · FMF
Anhui Tiankang Medical Technology...
General Hospital · 189d
Cleared Aug 24, 2021
SKR 3000
K210619 · MQB
Konica Minolta, Inc.
Radiology · 176d
Cleared Aug 24, 2021
Shoulder Pacemaker
K210674 · IPF
Ncs Lab Srl
Physical Medicine · 172d
Cleared Aug 24, 2021
DreamWear Silicone Pillows Mask
K210844 · BZD
Respironics, Inc.
Anesthesiology · 155d
Cleared Aug 24, 2021
Disposable Nitrile Examination Gloves
K210897 · LZA
Shandong DS Safety Technology Co., Ltd.
General Hospital · 152d
Cleared Aug 24, 2021
Advantage-C PEEK Cervical lnterbody Fusion Device
K211501 · ODP
Lntelivation, LLC
Orthopedic · 102d
Cleared Aug 24, 2021
Nitrile Examination Gloves
K211515 · LZA
Beijing Reagent Latex Products Co., Ltd.
General Hospital · 99d
Cleared Aug 24, 2021
Disposable Vinyl Nitrile Synthetic Gloves Powder Free
K211516 · LYZ
Tangshan Hongyun Plastic Products...
General Hospital · 99d
Cleared Aug 24, 2021
TurboHawk Plus Directional Atherectomy System
K212027 · MCW
Medtronic, Inc.
Cardiovascular · 56d
Cleared Aug 23, 2021
SmartGuard Anti-Snoring Device
K200657 · LRK
Smartguard Rx, Inc.
Dental · 529d