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

Filters: Cleared only ×
175,820 results
15241–15264 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 05, 2022
Jplant
K211978 · DZE
Jj Medical Co., Ltd.
Dental · 194d
Cleared Jan 05, 2022
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully...
K212115 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 182d
Cleared Jan 05, 2022
BHA100 Series Braun Clear Hearing Aid
K212609 · QDD
Kaz USA, Inc., A Helen of Troy Company
Ear, Nose, Throat · 141d
Cleared Jan 05, 2022
Vinyl Exam Gloves
K213019 · LYZ
Hebei Astro Medical Supply Co., Ltd.
General Hospital · 107d
Cleared Jan 05, 2022
PASS LP™ Spinal System, CD Horizon™ Spinal System
K213281 · NKB
Medicrea International SA
Orthopedic · 96d
Cleared Jan 05, 2022
PRO-DENSE LoVisc Bone Graft Substitute
K213342 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Jan 05, 2022
BTL-899A
K213344 · GEI
BTL Industries, Inc.
General & Plastic Surgery · 90d
Cleared Jan 05, 2022
MPO Hip Instruments
K213816 · JDI
Microport Orthopedics, Inc.
Orthopedic · 29d
Cleared Jan 05, 2022
MPO Knee Instruments
K213817 · MBH
Microport Orthopedics, Inc.
Orthopedic · 29d
Cleared Jan 05, 2022
Self-adhesive Electrode
K213879 · GXY
Bozhou Rongjian Medical Appliance...
Neurology · 23d
Cleared Jan 05, 2022
FORZA XP Expandable Spacer System
K213951 · MAX
Orthofix US, LLC
Orthopedic · 19d
Cleared Jan 04, 2022
InnoClip Disposable Clip Applier, InnoClip Clip Applier
K202994 · FZP
Taiwan Surgical Corporation
General & Plastic Surgery · 460d
Cleared Jan 04, 2022
DynaFuse Fixation System
K203595 · HWC
MedShape, Inc.
Orthopedic · 391d
Cleared Jan 04, 2022
HP358EA Electrically Powered Wheelchair
K211647 · ITI
Kunshan Hi-Fortune Health Products...
Physical Medicine · 221d
Cleared Jan 04, 2022
restor3d Pin Implants
K211789 · HTY
Restor3d
Orthopedic · 208d
Cleared Jan 04, 2022
Medical Surgical Mask
K212299 · FXX
Wepon Medical Technology Co., Ltd.
General Hospital · 166d
Cleared Jan 04, 2022
Disposable Medical Surgical Mask
K212375 · FXX
Jiangxi Bestgrand Health Technology...
General Hospital · 158d
Cleared Jan 04, 2022
T-Edge 10, T-Edge 11
K213080 · FLE
Tuttnauer , Ltd.
General Hospital · 103d
Cleared Jan 04, 2022
Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle
K213831 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 27d
Cleared Jan 03, 2022
VUZE System
K210830 · LLZ
Vuze Medical , Ltd.
Radiology · 290d
Cleared Jan 03, 2022
Medline Smoke Evacuation Shroud
K213068 · FYD
Medline Industries, Inc.
General Hospital · 102d
Cleared Jan 03, 2022
Disposable Nitrile Medical Powder-free Glove
K213187 · LZA
Fujian Chunhui Medical Supply Co., Ltd.
General Hospital · 96d
Cleared Jan 02, 2022
Sterisystem Dry-Base Instrument Tray
K203177 · KCT
O&M Halyard, Inc.
General Hospital · 433d
Cleared Dec 30, 2021
Tzoar 207 Negative Pressure Wound Therapy (NPWT) System
K202898 · OMP
Lightstone Medical Products (Ningbo)...
General & Plastic Surgery · 457d