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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
12673–12696 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 2022
Synergy Marble (Model: Opasm)
K220064 · OHS
Yrs Group, Inc.
General & Plastic Surgery · 193d
Cleared Jul 22, 2022
C-Stem AMT LE Prosthesis
K220216 · JDI
Depuy Ireland UC
Orthopedic · 177d
Cleared Jul 22, 2022
Kentrospine PSS Pedicle Screw System
K220486 · NKB
Rivarp Medical Private Limited
Orthopedic · 150d
Cleared Jul 22, 2022
AI4CMR v1.0
K220624 · LLZ
Ai4medimaging Medical Solutions S.A.
Radiology · 141d
Cleared Jul 22, 2022
Vivid E80, Vivid E90, Vivid E95
K220882 · IYN
Ge Medical Systems Ultrasound And
Radiology · 119d
Cleared Jul 22, 2022
SECURE-LOCK
K220906 · HTY
Xiros, Ltd.
Orthopedic · 115d
Cleared Jul 22, 2022
EchoPAC Software Only, EchoPAC Plug-in
K220940 · QIH
GE Medical Systems Ultrasound and...
Radiology · 113d
Cleared Jul 22, 2022
Disposable Medical Face Mask (ear loop)
K221196 · FXX
Xiantao Topmed Nonwoven Protective...
General Hospital · 88d
Cleared Jul 22, 2022
TargetCool
K221234 · GEH
Recensmedical, Inc.
General & Plastic Surgery · 84d
Cleared Jul 22, 2022
14HQ701G-B
K221394 · MQB
Lg Electronics.Inc
Radiology · 70d
Cleared Jul 22, 2022
10HQ701G-B
K221461 · MQB
Lg Electronics.Inc
Radiology · 64d
Cleared Jul 22, 2022
PreXion3D Explorer PRO
K221525 · OAS
Prexion Corporation
Radiology · 57d
Cleared Jul 22, 2022
Align Lumbar Interbody Fusion System
K221535 · MAX
Acuity Surgical Devices, LLC
Orthopedic · 56d
Cleared Jul 21, 2022
Wei Nasal Jet Tube
K211543 · BTR
Well Lead Medical Co., Ltd.
Anesthesiology · 428d
Cleared Jul 21, 2022
BTI Interna Narrow/Plus Dental Implant System UnicCa
K211952 · DZE
B.T.I. Biotechnology Institute, Sl.
Dental · 393d
Cleared Jul 21, 2022
Syringe with permanently attached needle
K213158 · FMF
Berpu Medical Technology Co., Ltd.
General Hospital · 296d
Cleared Jul 21, 2022
Insufflation Retention Device
K213773 · FDF
Bpendo, LLC
Gastroenterology & Urology · 231d
Cleared Jul 21, 2022
Celerity Incubator
K213881 · FRC
STERIS Corporation
General Hospital · 220d
Cleared Jul 21, 2022
Pump Alignment Syringe
K220184 · FMF
Jiangsu Caina Medical Co.,Ltd
General Hospital · 178d
Cleared Jul 21, 2022
Manual Wheelchair
K220671 · IOR
Hebei Ruilangde Medical Equipment...
Physical Medicine · 136d
Cleared Jul 21, 2022
Life Scope PT BSM-1700 Series Bedside Monitor
K220976 · KOI
Nihon Kohden Corporation
Anesthesiology · 108d
Cleared Jul 21, 2022
Cionic Neural Sleeve NS-100
K221823 · GZI
Cionic
Physical Medicine · 28d
Cleared Jul 20, 2022
Root Apex Locator
K212178 · LQY
Foshan Coxo Medical Instrument Co., Ltd.
Dental · 373d
Cleared Jul 20, 2022
AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial...
K213060 · KTI
Micro-Tech (Nanjing) Co., Ltd.
Anesthesiology · 301d