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
21769–21792 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 2019
Europa Pedicle Screw System
K192268 · NKB
MiRus, LLC
Orthopedic · 62d
Cleared Oct 22, 2019
LipiFlow Thermal Pulsation System
K192623 · ORZ
Tearscience, Inc.
Ophthalmic · 29d
Cleared Oct 22, 2019
RCT800
K192737 · OAS
Ray Co., Ltd.
Radiology · 25d
Cleared Oct 22, 2019
ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic...
K192835 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared Oct 21, 2019
Servo Guard
K182862 · CAH
Maquet Critical Care AB
General Hospital · 375d
Cleared Oct 21, 2019
BD Insulin Syringe
K190054 · FMF
Becton, Dickinson and Company
General Hospital · 283d
Cleared Oct 21, 2019
Fusion Silastic System
K190136 · KWH
Fusion Orthopedics, LLC
Orthopedic · 265d
Cleared Oct 21, 2019
FORE-SIGHT ELITE Tissue Oximeter Module
K190270 · MUD
Cas Medical Systems, Inc.
General & Plastic Surgery · 255d
Cleared Oct 21, 2019
BD MAX Vaginal Panel
K191957 · PQA
Geneohm Sciences Canada, Inc. (Bd...
Microbiology · 90d
Cleared Oct 21, 2019
Sterilucent VH2O2 Chemical Indicators
K191999 · JOJ
Sterilucent, Inc.
General Hospital · 87d
Cleared Oct 21, 2019
PENTAX Medical ED-3490TK Video Duodenoscope
K192280 · FDT
Pentax Medical
Gastroenterology & Urology · 60d
Cleared Oct 21, 2019
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope...
K192616 · FTM
Aziyo Biologics, Inc.
General & Plastic Surgery · 28d
Cleared Oct 21, 2019
Omnipod Insulin Management System, Omnipod DASH Insulin Management System
K192659 · LZG
Insulet Corporation
General Hospital · 26d
Cleared Oct 20, 2019
EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One
K190124 · ELC
E.M.S Electro Medical Systems S.A
Dental · 268d
Cleared Oct 19, 2019
NuVasive® Reline® 4.5-5.0 System
K190636 · NKB
Nu Vasive, Incorporated
Orthopedic · 221d
Cleared Oct 19, 2019
Altapore Shape
K191513 · MQV
Baxter Healthcare Corporation
Orthopedic · 134d
Cleared Oct 19, 2019
Arthrex SwiveLock Anchor
K192532 · MAI
Arthrex, Inc.
Orthopedic · 33d
Cleared Oct 18, 2019
LIPOcel
K181896 · OHV
Jeisys Medical, Inc.
General & Plastic Surgery · 459d
Cleared Oct 18, 2019
Care Orchestrator Essence
K183226 · BZD
Respironics, Inc.
Anesthesiology · 332d
Cleared Oct 18, 2019
RTHawk, HeartVista Cardiac Package
K183274 · LNH
Heartvista, Inc.
Radiology · 329d
Cleared CT Oct 18, 2019
SomnaPatch
K183625 · MNR
Respironics, Inc.
Anesthesiology · 296d
Cleared Oct 18, 2019
BIAFINE Topical Cream
K190342 · FRO
Bausch Health Americas Incorporated
General & Plastic Surgery · 246d
Cleared Oct 18, 2019
Evolve Breast Pump
K190465 · HGX
Hygeia II Medical Group, Inc.
Obstetrics & Gynecology · 234d
Cleared Oct 18, 2019
QT Scanner 2000 Model A
K190646 · IYO
Qt Ultrasound, LLC
Radiology · 219d