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
28705–28728 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 2017
Pinpoint GT Needles
K163216 · BSP
C.R. Bard, Inc.
Anesthesiology · 223d
Cleared Jun 27, 2017
Stellar LEAP
K163432 · IOR
Pdg Product Design Group, Inc.
Physical Medicine · 202d
Cleared Jun 27, 2017
Tranquil Interbody System
K170297 · MAX
Nexus Spine, LLC
Orthopedic · 147d
Cleared Jun 27, 2017
OWL RF INSULATED CANNULAE
K170708 · GXI
Diros Technology, Inc.
Neurology · 111d
Cleared Jun 27, 2017
Powder-Free Clear Vinyl Patient Examination Gloves
K170735 · LYZ
Zibo Yue Fan Medical Products Co, Ltd.
General Hospital · 109d
Cleared Jun 27, 2017
Halcyon
K170817 · IYE
Varian Medical Systems, Inc.
Radiology · 99d
Cleared Jun 27, 2017
Contact Lens Case Round Glasses
K171163 · LRX
Fiftytwoways, Ltd.
Ophthalmic · 68d
Cleared Jun 27, 2017
RayStation
K171536 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 33d
Cleared Jun 27, 2017
Distal Elbow Plating System
K171590 · HRS
Skeletal Dynamics, LLC
Orthopedic · 27d
Cleared Jun 27, 2017
Smith & Nephew 25 Fluid Management System
K171794 · HRX
Smith & Nephew, Inc.
Orthopedic · 11d
Cleared Jun 26, 2017
SpringTMS
K162797 · OKP
Eneura, Inc.
Neurology · 265d
Cleared Jun 26, 2017
Swedge™ Pedicle Screw Fixation System
K170045 · NKB
Spinal Resources, Inc.
Orthopedic · 172d
Cleared Jun 26, 2017
LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100...
K170416 · DJR
Lin-Zhi International, Inc.
Toxicology · 136d
Cleared Jun 26, 2017
PROCOTYL® PRIME Acetabular Cup System
K170444 · LPH
Microport Orthopedics, Inc.
Orthopedic · 132d
Cleared Jun 26, 2017
CardioLogs ECG Analysis Platform
K170568 · DPS
Cardiologs Technologies
Cardiovascular · 119d
Cleared Jun 26, 2017
Sprint System, Single Procedure Kit, Sprint System with Pad II, Single...
K170902 · NHI
Spr Therapeutics, LLC
Neurology · 90d
Cleared Jun 26, 2017
NuVasive® CoRoent® Thoracolumbar System
K170962 · MAX
Nu Vasive, Incorporated
Orthopedic · 87d
Cleared Jun 23, 2017
Cerdak Basic
K153138 · FRO
Bu Polysciences Equipment & Trading, LLC
General & Plastic Surgery · 602d
Cleared Jun 23, 2017
HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit
K162582 · HIF
Fisher & Paykel Healthcare
Obstetrics & Gynecology · 281d
Cleared Jun 23, 2017
Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl
K162678 · LGD
Roche Diagnostics
Microbiology · 270d
Cleared Jun 23, 2017
Babyleo TN500
K162821 · FMZ
Draegerwerk AG & CO Kgaa
General Hospital · 259d
Cleared Jun 23, 2017
Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8...
K162897 · OYE
Beckman Coulter
Immunology · 249d
Cleared Jun 23, 2017
Gemini Sterilization Wrap
K162993 · FRG
Medline Industries, Inc.
General Hospital · 239d
Cleared Jun 23, 2017
hypodermic Pinpoint™ GT Needle
K163437 · PVZ
C.R. Bard, Inc.
General Hospital · 198d