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
2497–2520 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 07, 2019
Introcan Safety 3 Closed IV Catheter
K182870 · FOZ
B.Braun Medical, Inc.
General Hospital · 146d
Cleared Mar 05, 2019
MAC Medical D-Series Blanket and Solution Warming Cabinets
K180842 · LGZ
Mac Medical, Inc.
General Hospital · 340d
Cleared Mar 01, 2019
PRO-LITE Sterilization Tray
K183402 · KCT
STERIS Corporation
General Hospital · 84d
Cleared Mar 01, 2019
Vis-U-All Low Temperature Sterilization Pouch/Tubing
K183401 · FRG
STERIS Corporation
General Hospital · 84d
Cleared Mar 01, 2019
Lead-free Chemical Indicators for Steam Sterilization
K181788 · JOJ
Kem Medical Products Corp.
General Hospital · 239d
Cleared Mar 01, 2019
BD Vacutainer Eclipse UltraFill Blood Collection Needle
K181730 · FMI
Becton, Dickinson and Company
General Hospital · 245d
Cleared Feb 28, 2019
Digital Thermometer
K182629 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 157d
Cleared Feb 26, 2019
3M Comply Hydrogen Peroxide Chemical Indicator
K183211 · JOJ
3M Company
General Hospital · 99d
Cleared Feb 26, 2019
Omni Instrument Tray
K182052 · KCT
Hologic, Inc.
General Hospital · 210d
Cleared Feb 26, 2019
Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter...
K181870 · FPA
Wuhan W.E.O Science & Technology...
General Hospital · 229d
Cleared Feb 22, 2019
Babyleo TN500
K182859 · FMZ
Dragerwerk AG & CO Kgaa
General Hospital · 134d
Cleared Feb 15, 2019
3M Comply Hydrogen Peroxide Indicator Tape
K183209 · JOJ
3M Company
General Hospital · 88d
Cleared Feb 15, 2019
Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP,...
K181393 · KPE
Valmed S.R.L.
General Hospital · 262d
Cleared Feb 13, 2019
U&U Blood Collection Sets
K181508 · FMI
U&U Medical Technology Co, Ltd.
General Hospital · 251d
Cleared Feb 07, 2019
SafeAir Smoke Evacuator compact
K182224 · FYD
Lina Medical Aps
General Hospital · 175d
Cleared Feb 05, 2019
Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with...
K183132 · LZC
O&M Halyard, Inc.
General Hospital · 84d
Cleared Feb 04, 2019
d-Nav System
K181916 · NDC
Hygieia, Inc.
General Hospital · 202d
Cleared Feb 01, 2019
Endoscope Sterilization Tray
K183139 · KCT
Intuitive Surgical, Inc.
General Hospital · 80d
Cleared Jan 31, 2019
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900
K182827 · MED
STERIS Corporation
General Hospital · 118d
Cleared Jan 28, 2019
Quantum Blood and IV Fluid Infusion Warmer
K181775 · LGZ
Life Warmer, Inc.
General Hospital · 209d
Cleared Jan 28, 2019
Greenmedi Safety Filter Syringe
K173743 · MEG
Sang-A Frontec Co., Ltd.
General Hospital · 417d
Cleared Jan 24, 2019
Surgical Face Mask
K182514 · FXX
Xiantao Zhibo Non-Woven Products Co.,...
General Hospital · 134d
Cleared Jan 22, 2019
FEMON Banana Thermometer
K180767 · FLL
Life Science Technology, Inc.
General Hospital · 305d
Cleared Jan 18, 2019
Kurin PIV Blood Collection Set with High Pressure
K181895 · JKA
Kurin, Inc.
General Hospital · 186d