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
30001–30024 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 2017
FlexCath Select Steerable Shealth and Dilator
K163268 · DYB
Medtronic Cryocath, LP
Cardiovascular · 73d
Cleared Feb 02, 2017
HA Minuteman G3-R MIS Fusion Plate
K163428 · PEK
Spinal Simplicity
Orthopedic · 58d
Cleared Feb 02, 2017
NovaGuard SA Pro Safety System
K163511 · MEG
West Pharmaceutical Services, Inc.
General Hospital · 49d
Cleared Feb 02, 2017
Aquilion Lightning, TSX-036A/1, V8.4
K170019 · JAK
Toshibamedical Systems Corporation
Radiology · 30d
Cleared Feb 02, 2017
ProMIS™ Fixation System
K170061 · NKB
Premia Spine, Ltd.
Orthopedic · 27d
Cleared Feb 01, 2017
Life Spine Metatarsal Hemi Implant
K161279 · KWD
Life Spine, Inc.
Orthopedic · 271d
Cleared Feb 01, 2017
U2 Total Knee System, PSA Tibial Insert
K161360 · JWH
United Orthopedic Corporation
Orthopedic · 261d
Cleared Feb 01, 2017
Memodyn Staple
K161587 · JDR
Austin & Associates, Inc./Telos...
Orthopedic · 238d
Cleared Feb 01, 2017
iHealth Wireless Blood Pressure Monitor
K162144 · DXN
Andon Health Co, Ltd.
Cardiovascular · 184d
Cleared Feb 01, 2017
PicoWay Laser System
K162454 · GEX
Syneron Candela Corporation
General & Plastic Surgery · 153d
Cleared Feb 01, 2017
Twin-Pass Torque
K162467 · DQY
Vascular Solutions, Inc.
Cardiovascular · 152d
Cleared Feb 01, 2017
Pre-Formed Penile Silicone Block
K162624 · MIB
International Medical Devices, Inc.
General & Plastic Surgery · 134d
Cleared Feb 01, 2017
Exactech® Equinoxe® Preserve Stem
K162726 · PHX
Exactech, Inc.
Orthopedic · 125d
Cleared Feb 01, 2017
MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface
K162958 · DTR
Medtronic, Inc.
Cardiovascular · 100d
Cleared Feb 01, 2017
VITEK 2 AST-GN Tobramycin (/= 16 ug/mL)
K163083 · LON
bioMerieux, Inc.
Microbiology · 90d
Cleared Feb 01, 2017
Lyme B. burgdorferi (IgG) MarStripe Test
K163095 · LSR
Trinity Biotech
Microbiology · 89d
Cleared Feb 01, 2017
Stealth Staple System
K163440 · JDR
First Ray, LLC
Orthopedic · 55d
Cleared Jan 31, 2017
Medline Non-Surgical Isolation Gown-
K160471 · FYC
Medline Industries, Inc.
General Hospital · 347d
Cleared Jan 31, 2017
IDS-iSYS Intact PTHN
K161158 · CEW
Immunodiagnostic Systems , Ltd.
Chemistry · 281d
Cleared Jan 31, 2017
OsteoCool V-3 RF Ablation System
K161949 · GEI
Baylis Medical Company, Inc.
General & Plastic Surgery · 200d
Cleared Jan 31, 2017
Acclarix LX8 Diagnostic Ultrasound System
K162055 · IYN
Edan Instruments, Inc.
Radiology · 190d
Cleared Jan 31, 2017
HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with...
K162381 · LZA
Healthy Glove Co., Ltd.
General Hospital · 160d
Cleared Jan 31, 2017
NobelClinician, DTX Studio implant
K163122 · LLZ
Nobel Biocare AB
Radiology · 84d
Cleared Jan 31, 2017
Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302,...
K163170 · OAP
Capillus, LLC
General & Plastic Surgery · 78d