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
145–168 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 07, 2025
ulrichINJECT CT Motion (XD 8000)
K251295 · IZQ
Ulrich GmbH & Co. KG
General Hospital · 196d
Cleared Nov 05, 2025
Polyshield Safety IV Catheters
K252677 · FOZ
Poly Medicure Limited
General Hospital · 72d
Cleared Nov 04, 2025
PRIMED Surgical and Procedure Masks
K252964 · FXX
Primed Medical Products, Inc.
General Hospital · 48d
Cleared Nov 04, 2025
Merit Syringe
K250853 · FMF
Merit Medical Systems, Inc.
General Hospital · 228d
Cleared Oct 31, 2025
Chex-All Sterilization Pouches and Tubes
K250306 · FRG
Propper Manufacturing Co., Inc.
General Hospital · 270d
Cleared Oct 30, 2025
BD Alaris Pump Infusion Set
K250325 · FPA
Carefusion (Bd)
General Hospital · 267d
Cleared Oct 27, 2025
Disposable Vinyl Examination Gloves
K252467 · LYZ
Viet Phu Trade and Import Export Co.,...
General Hospital · 82d
Cleared Oct 24, 2025
Medline Bag Decanter
K250345 · LHI
Medline Industries, LP
General Hospital · 260d
Cleared Oct 23, 2025
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs,...
K250861 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 216d
Cleared Oct 22, 2025
Giraffe OmniBed Carestation (CS1)
K251663 · FMZ
Datex-Ohmeda, Inc.
General Hospital · 145d
Cleared Oct 21, 2025
Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor
K253033 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 29d
Cleared Oct 17, 2025
Program insite® Powder-Free, Disposable Nitrile Exam Gloves
K252075 · LZA
Program Insite, LLC
General Hospital · 107d
Cleared Oct 16, 2025
Profoject™ Disposable Needle
K252631 · FMI
CMT Health PTE., Ltd.
General Hospital · 57d
Cleared Oct 15, 2025
Sure-Fine Insulin Syringes
K250510 · FMF
Shina Med Corporation
General Hospital · 236d
Cleared Oct 14, 2025
Community Containers (Flap and Daisy)
K252637 · MMK
Keter Canada, Inc.
General Hospital · 55d
Cleared Oct 14, 2025
PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)
K251874 · MMK
Pureway Compliance, Inc.
General Hospital · 118d
Cleared Oct 14, 2025
FlowArt® Vial Access Device Vented
K251715 · LHI
Asset Medikal
General Hospital · 132d
Cleared Oct 10, 2025
SoClean 3+
K243815 · QXQ
Soclean, Inc.
General Hospital · 303d
Cleared Oct 08, 2025
BD Saf-T-Intima™ Subcutaneous Catheter System
K251422 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 154d
Cleared Sep 25, 2025
Steripath® Flow™ Blood Collection System
K251812 · JKA
Magnolia Medical Technologies
General Hospital · 105d
Cleared Sep 24, 2025
MEDRAD Centargo CT Injection System
K252689 · IZQ
Imaxeon Pty, Ltd.
General Hospital · 29d
Cleared Sep 24, 2025
Celerity™ 20 HP Biological Indicator
K252680 · FRC
STERIS Corporation
General Hospital · 30d
Cleared Sep 17, 2025
Vitaform Procedural Mask - Blue (Vitaform Blue)
K251902 · FXX
Vitacore Industries, Inc.
General Hospital · 89d
Cleared Sep 16, 2025
Medline Microtek C-Flo Bag Decanter, Sterile (2000S)
K251676 · LHI
Microtek Medical, LLC
General Hospital · 109d