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
2521–2544 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 16, 2019
Powder Free Nitrile Patient Examination Gloves, Blue Color
K181106 · LZA
Jiangsu Dongxin Medical Technology...
General Hospital · 265d
Cleared Jan 16, 2019
Disposable Ultra Reinforced Surgical Gown
K173847 · FYA
Xiantao Rayxin Medical Products Co.,...
General Hospital · 393d
Cleared Jan 11, 2019
Tamper Evident Cap with Male Luer Lock
K182545 · FPA
International Medical Industries, Inc.
General Hospital · 116d
Cleared Jan 10, 2019
Infrared Ear Thermometer
K180387 · FLL
Hetaida Technology Co., Ltd.
General Hospital · 332d
Cleared Jan 10, 2019
Advocate Non-Contact Infrared Thermometer
K180355 · FLL
Broadmaster Biotech, Corp.
General Hospital · 336d
Cleared Jan 09, 2019
Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested...
K181047 · KGO
Smart Glove Corporation Sdn. Bhd.
General Hospital · 265d
Cleared Jan 08, 2019
Omnipod Insulin Management System, Omnipod DASH Insulin Management System
K182630 · LZG
Insulet Corporation
General Hospital · 106d
Cleared Jan 04, 2019
Celerity HP Chemical Indicator (CI)
K183295 · JOJ
Steris Corporations
General Hospital · 38d
Cleared Jan 04, 2019
VERIFY VH202 Indicator Tape
K183293 · JOJ
STERIS Corporation
General Hospital · 38d
Cleared Jan 03, 2019
PRO-LITE Sterilization Tray
K183301 · KCT
STERIS Corporation
General Hospital · 37d
Cleared Jan 03, 2019
VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological...
K183300 · FRC
Steris Corporations
General Hospital · 37d
Cleared Jan 03, 2019
Vis-U-All Low Temperature Sterilization Pouch/Tubing
K183297 · FRG
STERIS Corporation
General Hospital · 37d
Cleared Jan 03, 2019
CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack
K183294 · FRC
STERIS Corporation
General Hospital · 37d
Cleared Jan 03, 2019
Cufitec Surgical Mask
K182766 · OUK
Nbc Meshtec, Inc.
General Hospital · 97d
Cleared Jan 03, 2019
V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature...
K182568 · MLR
STERIS Corporation
General Hospital · 107d
Cleared Jan 03, 2019
Maxcon Sharps Container
K180984 · MMK
Ningbo Maxcon Medical Technology Co.,...
General Hospital · 265d
Cleared Jan 03, 2019
Maxcon Two Gallon Chemotherapy Container
K180983 · MMK
Ningbo Maxcon Medical Technology Co.,...
General Hospital · 265d
Cleared Jan 03, 2019
Safe Secure Sterilization Pouches and Rolls
K180139 · FRG
Safe Secure Packing Co., Ltd.
General Hospital · 350d
Cleared Jan 02, 2019
Infrared Thermometer
K181215 · FLL
Shenzhen Finicare Co., Ltd.
General Hospital · 240d
Cleared Dec 27, 2018
STERRAD VELOCITY Biological Indicator
K182404 · FRC
Advanced Sterilization Products (Asp)
General Hospital · 114d
Cleared Dec 21, 2018
Nitrile Glove Powder Free White
K183068 · LZA
Haining Medical Products Co., Ltd.
General Hospital · 46d
Cleared Dec 21, 2018
Disposable Temperature Probe
K182755 · FLL
Shenzhen Caremed Medical Technology...
General Hospital · 84d
Cleared Dec 21, 2018
SterilContainer S System
K182032 · KCT
Aesculap, Inc.
General Hospital · 144d
Cleared Dec 20, 2018
BD Contoured Base Pen Needle
K182320 · FMI
Becton, Dickinson and Company
General Hospital · 115d