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
16273–16296 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 07, 2021
OneLIF Intervertebral Body Replacement System
K211769 · OVD
Novapproach Spine
Orthopedic · 91d
Cleared Sep 06, 2021
SANSIN Tubing Sets for Hemodialysis
K202796 · FJK
Jiangxi Sanxin Medtec Co., Ltd.
Gastroenterology & Urology · 348d
Cleared Sep 05, 2021
Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T,...
K211736 · NUH
Shenzhen Osto Technology Company Limited
Neurology · 90d
Cleared Sep 05, 2021
3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228
K212081 · JOJ
3M Company
General Hospital · 65d
Cleared Sep 03, 2021
Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry...
K201305 · CAC
Atrium Medical Corporation
Cardiovascular · 476d
Cleared Sep 03, 2021
Dentilube Spray
K202689 · LFD
Oxy2plus, LLC
Dental · 353d
Cleared Sep 03, 2021
Dental Low-speed Handpieces and Accessories
K202786 · EFB
Microp Technology (Taiwan), Inc.
Dental · 346d
Cleared Sep 03, 2021
Male Latex Condom
K203536 · HIS
Global Protection Corp.
Obstetrics & Gynecology · 274d
Cleared Sep 03, 2021
Current Health Monitoring System Gen 2 (G2)
K210133 · MSX
Current Health
Cardiovascular · 227d
Cleared Sep 03, 2021
BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing,...
K210342 · ODC
STERIS Corporation
Gastroenterology & Urology · 210d
Cleared Sep 03, 2021
C-CURVE Interbody Fusion Device
K210470 · OVE
Medicrea International SA
Orthopedic · 198d
Cleared Sep 03, 2021
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder...
K210861 · KWS
Stryker GmbH
Orthopedic · 164d
Cleared Sep 03, 2021
LuxaPrint Ortho Plus
K210940 · MQC
Dmg Digital Enterprises SE
Dental · 158d
Cleared Sep 03, 2021
WoundExpress
K211200 · JOW
Huntleigh Healthcare , Ltd.
Cardiovascular · 134d
Cleared Sep 03, 2021
Infrared Thermometer, Model: HW-1
K211583 · FLL
Dongguan Simzo Electronic Technology...
General Hospital · 102d
Cleared Sep 03, 2021
AROMA GRAND
K211637 · GEX
Daeju Meditech Engineering Co., Ltd.
General & Plastic Surgery · 99d
Cleared Sep 03, 2021
Altor Safety 4-Ply Surgical Mask (Model:62232)
K211762 · FXX
Altor Safety, LLC
General Hospital · 87d
Cleared Sep 03, 2021
ADAS 3D
K212421 · LLZ
Adas3D Medical S.L.
Radiology · 30d
Cleared Sep 03, 2021
KARL STORZ Flexible HD Cysto-Urethroscope System
K212476 · FAJ
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 28d
Cleared Sep 02, 2021
MultiCath, AcQRate Dx Fixed Curve Catheter
K201445 · DRF
Biotronik, Inc.
Cardiovascular · 458d
Cleared Sep 02, 2021
Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5
K201612 · NUC
Viramal Limited
Obstetrics & Gynecology · 444d
Cleared Sep 02, 2021
RayPilot System
K203722 · IYE
Micropos Medical AB
Radiology · 255d
Cleared Sep 02, 2021
Nitrile Examination Gloves Powder Free (Blue)
K210868 · LZA
Great Eco Glove Sdn. Bhd.
General Hospital · 163d
Cleared Sep 02, 2021
Univers Revers Modular Glenoid System, Standard Augment Baseplates
K211074 · PHX
Arthrex, Inc.
Orthopedic · 143d