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
16393–16416 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 23, 2021
npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™
K201400 · QPX
Aatru Medical, LLC
General & Plastic Surgery · 452d
Cleared Aug 23, 2021
Disposable medical face mask
K202745 · FXX
Ningbo Jingeao Electronics, Inc.
General Hospital · 339d
Cleared Aug 23, 2021
DEKA SMARTPERIO
K203396 · NVK
El.En Electronic Engineering Spa
Dental · 278d
Cleared Aug 23, 2021
EzOrtho
K211793 · LLZ
Ewoosoft Co., Ltd.
Radiology · 74d
Cleared Aug 23, 2021
CLAREON MONARCH IV IOL Delivery System
K212039 · MSS
Alcon Laboratories, Inc.
Ophthalmic · 54d
Cleared Aug 23, 2021
6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF
K212105 · MQB
Pzmedical Technology Co., Ltd.
Radiology · 48d
Cleared Aug 23, 2021
RenovoCath
K212324 · MJN
Renovorx, Inc.
Cardiovascular · 28d
Cleared Aug 23, 2021
IMRIS iMRI 3T V
K212367 · LNH
Deerfield Imaging, Inc.
Radiology · 24d
Cleared Aug 21, 2021
Disposable Surgical Gowns
K202532 · FYA
Anhui Medpurest Medical Technology...
General Hospital · 354d
Cleared Aug 20, 2021
Powder Free Nitrile Examination Glove Black and Dual Color White-Blue
K201857 · LZA
Careplus (M) Sdn Bhd
General Hospital · 410d