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
601–624 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 01, 2023
BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free...
K233529 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 29d
Cleared Dec 01, 2023
CATHTONG III Tapered PICC Catheter
K233149 · LJS
L&Z Us, Inc.
General Hospital · 65d
Cleared Dec 01, 2023
Vial2Bag Advanced® 13mm Admixture Device
K230988 · LHI
West Pharma Services Il, Ltd.
General Hospital · 239d
Cleared Dec 01, 2023
Extension Set
K230528 · FPA
Medcaptain Life Science Co., Ltd.
General Hospital · 277d
Cleared Nov 30, 2023
NavaClick Injection System
K231877 · FMF
Lineage Biomedical, Inc.
General Hospital · 157d
Cleared Nov 30, 2023
L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters
K230669 · LJS
Argon Medical Devices
General Hospital · 265d
Cleared Nov 30, 2023
Insulin Syringe
K230061 · FMF
Anhui Hongyu Wuzhou Medical...
General Hospital · 325d
Cleared Nov 28, 2023
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs...
K232252 · LZA
Dehai (Shandong) Medical Gloves, Co.,...
General Hospital · 123d
Cleared Nov 28, 2023
VersaPump Infusion System
K230883 · PKP
Emed Technologies Corporation
General Hospital · 243d
Cleared Nov 27, 2023
SteriCap Safety Needle
K233343 · FMI
Ocuject, LLC
General Hospital · 59d
Cleared Nov 27, 2023
T-Top 10 & T-Top T-Top 11
K232658 · FLE
Tuttnauer U.S.A Co, Ltd.
General Hospital · 88d
Cleared Nov 21, 2023
TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant...
K233049 · PSW
Cs Medical, LLC
General Hospital · 57d
Cleared Nov 21, 2023
Medical Nitrile Examination Gloves
K232576 · LZA
Jiangsu Complete Sincerity Medical...
General Hospital · 88d
Cleared Nov 21, 2023
High Pressure Tubing
K232388 · DXT
Ningbo Dizegens Medical Science Co.,Ltd
General Hospital · 104d
Cleared Nov 21, 2023
SaviSafe Safety Device
K230287 · MEG
Suzhou Savicred Biotechnology Co., Ltd.
General Hospital · 292d
Cleared Nov 17, 2023
DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR...
K232538 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 87d
Cleared Nov 14, 2023
Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for...
K232461 · LZA
Kossan International Sdn Bhd
General Hospital · 91d
Cleared Nov 09, 2023
Flush Syringe (Prefilled 0.9% normal saline solution)
K231724 · NGT
Spm Medicare Pvt. , Ltd.
General Hospital · 149d
Cleared Nov 09, 2023
LILY Extension Tube and Needleless Connector
K222780 · FPA
Lily Medical Corporation
General Hospital · 421d
Cleared Nov 07, 2023
Biodegradable Medical surgical mask
K231155 · FXX
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 197d
Cleared Nov 06, 2023
Revital Cady
K231519 · FMF
Revital Healthcare (Epz) Limited
General Hospital · 165d
Cleared Nov 03, 2023
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile,...
K232266 · LZA
Better Care Plastic Technology Co., Ltd.
General Hospital · 95d
Cleared Nov 03, 2023
Freedom60 Infusion Pump
K231918 · FRN
Koru Medical Systems
General Hospital · 127d
Cleared Nov 03, 2023
ProSeal™ Closed System Administration Set
K230343 · FPA
Epic Medical Pte. , Ltd.
General Hospital · 268d