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
21121–21144 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 07, 2020
Avenger Radial Head System
K192754 · KWI
In2bones USA, LLC
Orthopedic · 99d
Cleared Jan 07, 2020
BioCardia 8F Morph DNA Deflectable Guide Catheter
K192774 · DQY
Biocardia
Cardiovascular · 99d
Cleared Jan 06, 2020
Multi-unit Abutments
K191123 · NHA
Medentika GmbH
Dental · 252d
Cleared Jan 06, 2020
TK Sterile Piston Syringe without Needle
K191642 · FMF
Anhui Tiankang Medical Technology...
General Hospital · 201d
Cleared Jan 06, 2020
SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed...
K192412 · EFB
Dentalez, Inc.
Dental · 124d
Cleared Jan 06, 2020
EVOL ha - D Lateral Interbody Fusion System
K192497 · MAX
Cutting Edge Spine, LLC
Orthopedic · 117d
Cleared Jan 06, 2020
Quadra-P
K192827 · LZO
Medacta International S.A.
Orthopedic · 96d
Cleared Jan 06, 2020
RS85 Diagnostic Ultrasound System
K192903 · IYN
Samsung Medison Co., Ltd.
Radiology · 83d
Cleared Jan 06, 2020
ViewPoint 6
K192917 · LLZ
Ge Medical Systems Ultrasound And
Radiology · 83d
Cleared Jan 06, 2020
MRIaudio PREM System with MRIview
K193102 · LNH
Mriaudio, Inc.
Radiology · 59d
Cleared Jan 06, 2020
R2P Destination Slender Guiding Sheath
K193125 · DYB
Terumo Medical Corporation
Cardiovascular · 55d
Cleared Jan 05, 2020
TriMed ASET Foot Plating System
K192696 · HRS
TriMed, Inc.
Orthopedic · 101d
Cleared Jan 03, 2020
Dillard Nasal Balloon Catheter
K181546 · LRC
Intuit Medical Products, LLC
Ear, Nose, Throat · 570d
Cleared Jan 03, 2020
Z5-BL
K190243 · DZE
Z-Systems AG
Dental · 331d
Cleared Jan 03, 2020
Endotics
K190669 · FDF
Era Endoscopy S.R.L.
Gastroenterology & Urology · 294d
Cleared Jan 03, 2020
Conformity stem, cemented
K191056 · JDI
United Orthopedic Corporation
Orthopedic · 259d
Cleared Jan 03, 2020
PiccGuard
K191195 · PZW
Piccguard, LLC
General Hospital · 245d
Cleared Jan 03, 2020
PALLAS 308/311 Solid-State UV Laser System
K191501 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 211d
Cleared Jan 03, 2020
Straumann Ceramic Healing Abutments
K192893 · NHA
Institut Straumann AG
Dental · 84d
Cleared Jan 03, 2020
Flex Body SPEEDER
K193140 · MOS
Quality Electrodynamics, LLC
Radiology · 51d
Cleared Jan 03, 2020
MPowRx Snoring Solution (also known as Good Morning Snore Solution)
K193239 · LRK
Mpowrx Health and Wellness Products...
Dental · 39d
Cleared Jan 03, 2020
SureMAX Family of Cervical Spacers
K193359 · ODP
Additive Implants, Inc.
Orthopedic · 30d
Cleared Jan 03, 2020
NeuroBlate System
K193375 · GEX
Monteris Medical,
Neurology · 29d
Cleared Jan 03, 2020
AlignRT Plus
K193431 · IYE
Vision Rt, Ltd.
Radiology · 24d