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
241–264 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Apr 25, 2025
Self Sealing Sterilization Pouches
K243721 · FRG
Wellmed Dental Medical Supply Co., Ltd.
General Hospital · 143d
Cleared Apr 25, 2025
Infrared Thermometer
K243082 · FLL
Guangzhou Daxin Health Technology...
General Hospital · 207d
Cleared Apr 24, 2025
GO-PEN®
K250262 · FMF
Go-Pen Aps
General Hospital · 85d
Cleared Apr 23, 2025
Nitrile Powder Free Examination Glove, Blue Tested for Use with 60...
K250944 · LZA
Gmp Medicare Sdn. Bhd.
General Hospital · 26d
Cleared Apr 18, 2025
DMRX 100ml Empty Container Solution
K250459 · KPE
Technoflex Sas.
General Hospital · 59d
Cleared Apr 18, 2025
FROG (Filter Removal of Glass)
K240355 · FMI
Carrtech Corp
General Hospital · 438d
Cleared Apr 14, 2025
STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)
K250802 · MLR
Advanced Sterilization Products, Inc.
General Hospital · 31d
Cleared Apr 09, 2025
CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion...
K242429 · SEF
Becton Dickinson Inc. (Bd)
General Hospital · 237d
Cleared Apr 08, 2025
Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50,...
K243027 · QLY
Hangzhou Sightnovo Medical Technology...
General Hospital · 193d
Cleared Apr 04, 2025
Turbett Surgical Instrument Pod (TS1500)
K250011 · FRG
Turbett Surgical
General Hospital · 92d