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
625–648 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Sep 15, 2023
The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource...
K223788 · FOZ
Medsource International, LLC
General Hospital · 270d
Cleared Sep 15, 2023
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead...
K221860 · QNQ
Poonglim Pharmatech, Inc.
General Hospital · 445d
Cleared Sep 14, 2023
PureWay 1.4 Quart Sharps Collector
K231484 · MMK
Pureway Compliance, Inc.
General Hospital · 114d
Cleared Sep 14, 2023
VitreJect® Needle
K230959 · FMI
Ocuject, LLC
General Hospital · 163d
Cleared Sep 13, 2023
AMSCO 600 Steam Sterilizer
K232485 · FLE
Steris
General Hospital · 28d
Cleared Sep 11, 2023
VERIFY Spore Test Strip for S40 Sterilant Concentrate
K231746 · OVY
STERIS Corporation
General Hospital · 88d
Cleared Sep 08, 2023
Sterile syringes for single use with/without needle
K231729 · FMI
Wepon Medical Technology Co., Ltd.
General Hospital · 87d
Cleared Sep 08, 2023
Sterile Auto-Disable Syringes with/without Needle for Single Use
K231727 · FMF
Wepon Medical Technology Co., Ltd.
General Hospital · 87d
Cleared Sep 08, 2023
Sterile Safety Hypodermic Needles for Single Use
K231723 · FMI
Wepon Medical Technology Co., Ltd.
General Hospital · 87d
Cleared Sep 08, 2023
Sterile Hypodermic Needles for Single Use
K231720 · FMI
Wepon Medical Technology Co., Ltd.
General Hospital · 87d