Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: General Hospital ×
17,825 results
649–672 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 04, 2023
Copioumed Chemotherapy Isolation Gown
K230135 · FYC
Copioumed International, Inc.
General Hospital · 259d
Cleared Oct 03, 2023
enspire 300 Series Automated Endoscope Reprocessor
K232918 · NZA
STERIS Corporation
General Hospital · 14d
Cleared Oct 03, 2023
SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500)
K232914 · MED
STERIS Corporation
General Hospital · 14d
Cleared Oct 03, 2023
Orchid Safety Release ValveTM
K232094 · QOI
Linear Health Sciences, LLC
General Hospital · 82d
Cleared Oct 02, 2023
Surgical face mask
K232359 · FXX
Kingstar Medical (Xianning) Co., Ltd.
General Hospital · 56d
Cleared Oct 02, 2023
Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with...
K232064 · LZA
Isikel Manufacturing, LLC
General Hospital · 83d
Cleared Oct 02, 2023
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with...
K230681 · LZA
Central Medicare Sdn Bhd
General Hospital · 203d
Cleared Sep 29, 2023
PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove
K231973 · KGO
Ineo Tech Sdn Bhd
General Hospital · 88d
Cleared Sep 29, 2023
SafeBreak® Vascular
K231957 · QOI
Lineus Medical
General Hospital · 88d
Cleared Sep 29, 2023
Chemotherapy Gloves
K230847 · LZA
3A Glove Sdn. Bhd.
General Hospital · 185d
Cleared Sep 29, 2023
UltraFlo-R Push Button Blood Collection Set
K220458 · JKA
Innovative Medical Technologies, Inc.
General Hospital · 589d
Cleared Sep 28, 2023
VeriSafe Safety sterile syringes
K231792 · FMF
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 100d
Cleared Sep 28, 2023
PIVO™ Pro Needle-free Blood Collection Device
K230865 · JKA
Becton Dickinson Infusion Therapy...
General Hospital · 183d
Cleared Sep 27, 2023
Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003,...
K231363 · NGT
Hantech Medical Device Co., Ltd.
General Hospital · 139d
Cleared Sep 25, 2023
BD Texium™ Needle-Free Syringe
K231888 · FMF
Care Fusion
General Hospital · 90d
Cleared Sep 22, 2023
CATHTONG™ II PICC Catheter
K232594 · LJS
L&Z Us, Inc.
General Hospital · 28d
Cleared Sep 22, 2023
CATHTONG™ II PICC Catheter
K232571 · LJS
L&Z Us, Inc.
General Hospital · 29d
Cleared Sep 22, 2023
Single-Use Latex Sterile Surgical Gloves (SG100)
K231446 · KGO
Fitone Latex Products Co., Ltd....
General Hospital · 127d
Cleared Sep 22, 2023
Nexiva™ Closed IV Catheter System with NearPort™ IV Access
K231239 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 147d
Cleared Sep 21, 2023
Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva
K231401 · FOZ
Poly Medicure Limited
General Hospital · 129d
Cleared Sep 21, 2023
Powder-Free Nitrile Examination Gloves
K223214 · LZA
Global Protection Corp.
General Hospital · 339d
Cleared Sep 20, 2023
Insulin Pen Needle
K230043 · FMI
Anhui Hongyu Wuzhou Medical...
General Hospital · 257d
Cleared Sep 18, 2023
MA-40, MA-112
K223835 · FRF
Medify Air, LLC
General Hospital · 270d
Cleared Sep 16, 2023
Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
K230483 · CAH
Passy-Muir, Inc.
General Hospital · 205d