FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
14137–14160 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 06, 2022
Penta Glove
K212847 · LZA
Pentavest Holdings Sdn Bhd
General Hospital · 121d
Cleared Jan 06, 2022
Gold Anchor
K213053 · IYE
Naslund Medical AB
Radiology · 106d
Cleared Jan 06, 2022
TOMTEC-ARENA
K213544 · QIH
Tomtec Imaging Systems GmbH
Radiology · 59d
Cleared Jan 06, 2022
ExactechGPS Total Shoulder Application, Equinoxe Planning Software
K213546 · OLO
Blue Ortho
Orthopedic · 59d
Cleared Jan 06, 2022
DePuy Corail AMT Hip Prosthesis
K213839 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Jan 06, 2022
ENEO TOTALE (Model: ENEOT947)
K213841 · OHS
Premier North America, Inc.
General & Plastic Surgery · 28d
Cleared Jan 05, 2022
Urethral Warming Catheter Kit
K211149 · GEH
Varian Medical Systems, Inc.
General & Plastic Surgery · 261d
Cleared Jan 05, 2022
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use...
K211318 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 250d
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