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
25–48 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 11, 2026
PRIMED AAMI Level 3 Open Back Gowns
K262007 · QPC
Primed Medical Products, Inc.
General Hospital · 88d
Cleared Sep 11, 2026
Ecomed Disposable Administration Sets
K254123 · FPA
Ecomed Solutions, LLC
General Hospital · 266d
Cleared Sep 09, 2026
Biodegradable Nitrile Powder Free Examination Glove, Green
K262542 · LZA
Top Glove Sdn. Bhd.
General Hospital · 48d
Cleared Sep 09, 2026
Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs...
K261793 · LZA
Maxter Healthcare, Inc.
General Hospital · 103d
Cleared Sep 08, 2026
Nitrile Powder Free Examination Glove, Blue Tested for Use with 32...
K260312 · LZA
Gmp Medicare Sdn. Bhd.
General Hospital · 221d
Cleared Sep 08, 2026
LiteSet Trays
K253988 · KCT
Nobel Biocare AB
General Hospital · 270d
Cleared Sep 04, 2026
Surgical and Prosthetic Trays
K261935 · KCT
Dentsply Sirona, Inc.
General Hospital · 87d
Cleared Sep 02, 2026
Cardinal Health Nitrile Blue Examination Gloves Tested for Use with...
K261749 · LZA
Cardinalhealth
General Hospital · 97d
Cleared Sep 02, 2026
Ruby Intravascular Catheter
K260432 · FOZ
Venocare, Inc.
General Hospital · 203d
Cleared Sep 01, 2026
PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug...
K261811 · QSO
Primed Medical Products, Inc.
General Hospital · 92d
Cleared Aug 26, 2026
Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns...
K260407 · FYA
Principle & Will Co., Ltd.
General Hospital · 198d
Cleared Aug 25, 2026
Promisemed X-Safety Pen Needle
K261719 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 91d
Cleared Aug 25, 2026
SOL-M Luer Lock Syringe with Exchangeable Needle Tray
K252184 · FMF
Sol-Millennium Medical, Inc.
General Hospital · 410d
Not Cleared Aug 19, 2026
Aletta® Autonomous Robotic Phlebotomy Device (ARPD™) (Gen1 US)
DEN250046 · SIW
Vitestro
General Hospital · 327d
Cleared Aug 18, 2026
NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE...
K260794 · LZA
Kossan International Sdn Bhd
General Hospital · 160d
Cleared Aug 14, 2026
Disposable Pen Injector (KXYC-03C02, KXYC-03A03)
K253747 · FMF
Jiangsu Enjosim Medical Technology...
General Hospital · 262d
Cleared Aug 11, 2026
VR® Personal Protective Level 4 Gown (VR Gowns)
K261115 · QPC
PolyConversions, Inc.
General Hospital · 130d
Cleared Aug 10, 2026
Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type...
K262427 · FMI
Hh Global Technology, Inc.
General Hospital · 25d
Cleared Aug 10, 2026
Unimpregnated Central Venous Catheter
K260165 · FOZ
Spectrum Vascular
General Hospital · 202d
Cleared Aug 07, 2026
Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)
K261028 · FYA
Yadu Medical (Henan) Co., Ltd.
General Hospital · 130d
Cleared Aug 07, 2026
Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R,...
K260933 · FMI
Hangzhou Qiantang Longyue...
General Hospital · 140d
Cleared Aug 05, 2026
Huahong Sharps Container (HHR-I, HHR-II)
K260845 · MMK
Tianjin Huahong Technology Co., Ltd.
General Hospital · 142d
Cleared Aug 03, 2026
VueJect® Ultrasound Enhancing Agent Delivery System
K262115 · IZQ
Acist Medical Systems, Inc.
General Hospital · 41d
Cleared Jul 29, 2026
Profoject™ Dual-Safety Pen Needles
K261829 · FMI
CMT Health PTE., Ltd.
General Hospital · 57d