FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,791 results
2353–2376 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 23, 2019
Diana ChemoClave Transfer Set
K190157 · ONB
Icu Medical
General Hospital · 266d
Cleared Oct 23, 2019
Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black...
K183562 · LZC
Encompass Industries Sdn. Bhd.
General Hospital · 307d
Cleared Oct 22, 2019
Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle...
K192001 · FRC
Sterilucent, Inc.
General Hospital · 88d
Cleared Oct 22, 2019
TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile,...
K190539 · FMG
Monumedical, LLC
General Hospital · 232d
Cleared Oct 21, 2019
Omnipod Insulin Management System, Omnipod DASH Insulin Management System
K192659 · LZG
Insulet Corporation
General Hospital · 26d
Cleared Oct 21, 2019
Sterilucent VH2O2 Chemical Indicators
K191999 · JOJ
Sterilucent, Inc.
General Hospital · 87d
Cleared Oct 21, 2019
BD Insulin Syringe
K190054 · FMF
Becton, Dickinson and Company
General Hospital · 283d
Cleared Oct 21, 2019
Servo Guard
K182862 · CAH
Maquet Critical Care AB
General Hospital · 375d
Cleared Oct 18, 2019
Quantum Blood and Fluid Warming System
K192325 · LGZ
Life Warmer, Inc.
General Hospital · 52d
Cleared Oct 18, 2019
Infrared Forehead Thermometer (Model IR-FT)
K191668 · FLL
Comper Chuangxiang (Beijing)...
General Hospital · 119d
Cleared Oct 18, 2019
Infrared Thermometer, Breeze model
K191283 · FLL
Suzhou Melodicare Medical Technology...
General Hospital · 158d
Cleared Oct 17, 2019
DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System,...
K190102 · DXT
Osprey Medical, Inc.
General Hospital · 268d
Cleared Oct 15, 2019
TotalShield II Surgical Helmet System
K192194 · FYA
Zimmer Surgical, Inc.
General Hospital · 63d
Cleared Oct 15, 2019
Infared Thermometer
K191251 · FLL
Shenzhen Calibeur Industries Co., Ltd.
General Hospital · 159d
Cleared Oct 15, 2019
Medtronic Transportation / Sterilization Cassettes
K190840 · KCT
Medtronic Sofamor Danek USA, Inc.
General Hospital · 197d
Cleared Oct 15, 2019
Vial Adapter Ø20 mm
K190149 · LHI
Avenir Performance Europeenne Medical...
General Hospital · 259d
Cleared Oct 11, 2019
K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2”...
K192057 · FMI
Terumo Europe N.V.
General Hospital · 71d
Cleared Oct 10, 2019
ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
K192210 · FLL
Fiab Spa
General Hospital · 57d
Cleared Oct 10, 2019
Halyard ONE-STEP* Sterilization Wrap
K192147 · FRG
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 63d
Cleared Oct 10, 2019
Instylla Delivery Kit
K191659 · FMF
Instylla, Inc.
General Hospital · 111d
Cleared Oct 10, 2019
Mercy babyTAPE
K191174 · PIR
Children'S Mercy Hospital
General Hospital · 162d
Cleared Oct 10, 2019
Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization...
K182184 · FRG
Mdk (Shanghai) Medical Packing Co., Ltd.
General Hospital · 423d
Cleared Oct 09, 2019
Nipro Syringe
K191359 · FMF
Nipro Medical Corporation
General Hospital · 141d
Cleared Oct 07, 2019
NIO-I
K190538 · FMI
Waismed, Ltd.
General Hospital · 217d