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
265–288 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 30, 2025
Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804)
K243010 · FXX
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 246d
Cleared May 29, 2025
ProSeal™ Bag Spike with Additive Port (423370ST, 423370)
K251340 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 29d
Cleared May 29, 2025
BiliWrap
K243372 · LBI
Gerium Medical, Ltd.
General Hospital · 211d
Cleared May 29, 2025
27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)
K243309 · FMI
Terumo Europe N.V.
General Hospital · 220d
Cleared May 28, 2025
MRidium 3870 MRI Infusion Pump System (3870)
K242752 · FRN
Iradimed Corporation
General Hospital · 258d
Cleared May 27, 2025
Helios+ UV-C System
K242604 · QXJ
Preventamed Technologies, Inc. Dba...
General Hospital · 270d
Cleared May 23, 2025
Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)
K244047 · JKA
Venocare, Inc.
General Hospital · 143d
Cleared May 22, 2025
YUWELL® Infrared Ear Thermometer (YHT100)
K250878 · FLL
Jiangsu Yuyue Medical Equipment&...
General Hospital · 59d
Cleared May 22, 2025
Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with...
K250630 · LZA
Basic Medical Technology, Inc.
General Hospital · 80d
Cleared May 16, 2025
Ruby Intravascular Catheter
K243105 · FOZ
Venocare, Inc.
General Hospital · 228d
Cleared May 13, 2025
Promisemed Safety Huber Needles
K251138 · PTI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 29d
Cleared May 13, 2025
Aesculap Aicon® Series Container System
K242762 · KCT
Aesculap, Inc.
General Hospital · 243d
Cleared May 09, 2025
Altaviz Intravitreal Syringe
K243322 · QLY
Altaviz, LLC
General Hospital · 198d
Cleared May 09, 2025
Tristel OPH
K242732 · QWS
Tristel Solutions , Ltd.
General Hospital · 241d
Cleared May 05, 2025
Dream Medi Sterile Surgical Gown (SurgicalGownUL)
K242937 · FYA
Dae Myung Chemical Co., Ltd. (Vietnam)
General Hospital · 222d
Cleared May 02, 2025
Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
K251048 · JOJ
STERIS Corporation
General Hospital · 29d
Cleared May 02, 2025
OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)
K250292 · FOZ
Skydance Vascular, Inc.
General Hospital · 91d
Cleared May 02, 2025
JetCan® Pro Safety Huber Needle
K242763 · FPA
Pfm Medical, Inc.
General Hospital · 232d
Cleared May 01, 2025
ONE TRAY® Sealed Sterilization Container System
K250029 · KCT
Innovative Sterilization Technologies
General Hospital · 115d
Cleared Apr 30, 2025
Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set
K250907 · JKA
Sol-Millennium Medical, Inc.
General Hospital · 35d
Cleared Apr 29, 2025
Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and...
K250069 · LYY
Comfort Rubber Gloves Industries Sdn....
General Hospital · 109d
Cleared Apr 29, 2025
Qitexio® 4-Way Stopcock (QIT014)
K242255 · FMG
Medex
General Hospital · 272d
Cleared Apr 25, 2025
VERIFY STEAM Integrating Indicator
K243876 · JOJ
STERIS Corporation
General Hospital · 128d
Cleared Apr 25, 2025
BD Alaris Infusion System with Guardrails Suite MX
K243855 · FRN
Carefusion 303, Inc.
General Hospital · 130d