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
19369–19392 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 2020
Braid
K200822 · LLZ
Braid.Health
Radiology · 136d
Cleared Aug 13, 2020
Univers Revers Modular Glenoid System, Half Augment Baseplate
K200895 · PHX
Arthrex, Inc.
Orthopedic · 132d
Cleared Aug 13, 2020
Limbus Contour
K201232 · LLZ
Limbus Ai, Inc.
Radiology · 98d
Cleared Aug 13, 2020
Syngo.via RT Image Suite
K201444 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 73d
Cleared Aug 13, 2020
Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator,...
K201916 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 34d
Cleared Aug 13, 2020
SpaceFlex Knee - 80mm Size
K201960 · MBB
G21, S.R.L.
Orthopedic · 30d
Cleared Aug 13, 2020
IlluminOss Photodynamic Bone Stabilization System
K201961 · QAD
Illuminoss Medical, Inc.
Orthopedic · 30d
Cleared CT Aug 12, 2020
SNA-001 Silver Photoparticle Topical Gel
K192620 · QCY
Sienna Biopharmaceuticals, Inc.
General & Plastic Surgery · 324d
Cleared Aug 12, 2020
UNIKO PointCloud™ Knee Instruments
K193312 · MBH
Unik Orthopedics, Inc.
Orthopedic · 257d
Cleared Aug 12, 2020
Orion
K200529 · LXV
Interacoustics A/S
Ear, Nose, Throat · 163d
Cleared Aug 12, 2020
VisualEyes
K200534 · GWN
Interacoustics A/S
Ear, Nose, Throat · 163d
Cleared Aug 12, 2020
Osteo-site Vertebral Balloon
K200763 · HRX
Izi Medical
Orthopedic · 141d
Cleared Aug 12, 2020
Tyece OTC TENS Model
K200838 · NUH
Tyece Limited
Neurology · 134d
Cleared Aug 12, 2020
SOMNOscreen plus
K201054 · OLV
Somnomedics GmbH
Neurology · 113d
Cleared Aug 12, 2020
BD PhaSeal Optima Closed System Drug Transfer Device
K201099 · ONB
Becton, Dickinson and Company
General Hospital · 110d
Cleared Aug 12, 2020
TruDi Curette
K201174 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 103d
Cleared Aug 12, 2020
Syringe Holder accessory
K201248 · MLY
Vapocoolshot, Inc.
Physical Medicine · 93d
Cleared Aug 12, 2020
Aurora Evacuator +Coag
K201637 · GEI
Rebound Therapeutics
General & Plastic Surgery · 57d
Cleared Aug 12, 2020
Surgical Mask
K201871 · FXX
C & S Paper Yunfu Co., Ltd.
General Hospital · 36d
Cleared Aug 11, 2020
Pointe Scientific Creatinine Kinase (CK) Reagent Set
K191296 · CGS
Medtest DX
Chemistry · 455d
Cleared Aug 11, 2020
Lateralized Glenosphere
K193175 · PHX
Medacta Inernational SA
Orthopedic · 267d
Cleared Aug 11, 2020
Disposable High Speed Air Turbine Handpiece
K193264 · EFB
Ningbo Hpdove Dental Instruments Co.,...
Dental · 259d
Cleared Aug 11, 2020
NuEra Tight, NuEra Tight EMS
K200359 · PBX
Bios S.R.L.
General & Plastic Surgery · 180d
Cleared Aug 11, 2020
HD Video Rhino Laryngoscope
K200740 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 141d