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
985–1008 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 16, 2022
SafeBreak Vascular
K222791 · QOI
Lineus Medical, LLC
General Hospital · 31d
Cleared Oct 14, 2022
Safety Insulin Pen Needles
K213183 · FMI
Zhejiang Kindly Medical Devices Co.,...
General Hospital · 380d
Cleared Oct 13, 2022
SCIg60 Infusion System
K222087 · PKP
Emed Technologies Corporation
General Hospital · 90d
Cleared Oct 12, 2022
MOST-T Autoclave
K220102 · FLE
Shinva Medical Instrument Co., Ltd.
General Hospital · 273d
Cleared Oct 11, 2022
Sol-M Luer Lock Syringe
K222744 · FMF
Sol-Millennium Medical, Inc.
General Hospital · 29d
Cleared Oct 11, 2022
Surgical Mask
K222335 · FXX
Luoyang Sunmed Devices Co., Ltd.
General Hospital · 69d
Cleared Oct 11, 2022
AAMI4 Isolation Gown
K214116 · FYC
Hubei Xinxin Non-Woven Co., Ltd.
General Hospital · 285d
Cleared Oct 08, 2022
Disposable Vinyl Examination Gloves
K223008 · LYZ
Jiangxi Handspro Products Solutions...
General Hospital · 9d
Cleared Oct 07, 2022
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy...
K222714 · LZA
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 29d
Cleared Oct 07, 2022
SteriTite Container System with MediTray Parts
K221492 · KCT
Case Medical, Inc.
General Hospital · 137d
Cleared Oct 07, 2022
Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105,...
K221170 · FLL
Shenzhen AOJ Medical Technology Co.,...
General Hospital · 168d
Cleared Oct 07, 2022
AMSafe NeuFlo Needleless Connector
K220267 · FPA
Amsino International, Inc.
General Hospital · 249d
Cleared Oct 07, 2022
YADU Surgical Gowns
K220092 · FYA
Henan Yadu Industrial Co., Ltd.
General Hospital · 268d
Cleared Oct 07, 2022
Disposable Sterile Syringe with permanently attached needle
K220057 · MEG
Shinva Ande Healthcare Apparatus Co.,...
General Hospital · 274d
Cleared Oct 06, 2022
Gemini Sterilization Wrap
K220365 · FRG
Medline Industries, LP
General Hospital · 240d
Cleared Oct 04, 2022
Sterile Safety Hypodermic Needles for Single Use
K221080 · FMI
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 175d
Cleared Oct 04, 2022
Sterile Hypodermic Syringes for Single Use
K221079 · FMF
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 175d
Cleared Oct 04, 2022
Sterile Hypodermic Syringes for Single Use with Safety Needles
K221073 · MEG
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 175d
Cleared Oct 04, 2022
Sterile Hypodermic Syringes for Single Use with Needles
K221068 · FMF
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 175d
Cleared Oct 04, 2022
Sterile Hypodermic Needles for Single Use
K221066 · FMI
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 175d
Cleared Oct 03, 2022
PCA Syringe Sets
K212262 · FPA
Baxter Healthcare Corporation
General Hospital · 440d
Cleared Oct 03, 2022
Velano Vascular Blood Collection Adapter 
K201237 · JKA
Velano Vascular
General Hospital · 879d
Cleared Oct 01, 2022
Disposable Nitrile Examination Glove
K222937 · LZA
Jiangsu Cureguard Glove Co., Ltd.
General Hospital · 5d
Cleared Sep 30, 2022
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization...
K222849 · NVE
Steris
General Hospital · 9d