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
25–48 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 02, 2026
HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology
K261897 · FRG
O&M Halyard, Inc.
General Hospital · 27d
Cleared Jun 24, 2026
AMSCO 700 Steam Sterilizer
K261055 · FLE
STERIS Corporation
General Hospital · 85d
Cleared Jun 24, 2026
Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for...
K252117 · LZA
Sw Technologies, Inc.
General Hospital · 352d
Cleared Jun 18, 2026
Powder Free Nitrile Examination Gloves Non-Sterile Black
K253824 · LZA
Kanglongda Vietnam Protection...
General Hospital · 199d
Cleared Jun 18, 2026
SteriBest® Sterilization Tray System
K253187 · KCT
Mastel Surgical
General Hospital · 265d
Cleared Jun 18, 2026
Sol-Glide Safety Needle
K253110 · FMF
Sol-Millennium Medical, Inc.
General Hospital · 267d
Cleared Jun 18, 2026
InstaTRU Instant Biological Indicator for Steam (IBI-05)
K251559 · QVB
True Indicating, LLC
General Hospital · 393d
Cleared Jun 17, 2026
FLEXI-PORT™ Power Injectable Implantable Port
K260916 · LJT
Portal Access, Inc.
General Hospital · 90d
Cleared Jun 17, 2026
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs...
K260867 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 92d
Cleared Jun 12, 2026
Profoject™ Safety Needle
K260514 · FMF
CMT Health PTE., Ltd.
General Hospital · 115d
Cleared Jun 12, 2026
MEDRAD® Imaging Bulk Package Transfer Spike
K253688 · PQH
Bayer Medical Care, Inc.
General Hospital · 203d
Cleared Jun 12, 2026
ADRx™ Admixture Device
K252987 · LHI
Epic Medical Pte. , Ltd.
General Hospital · 267d
Cleared Jun 10, 2026
Profoject™ Safety Pen Needles
K260855 · FMI
CMT Health PTE., Ltd.
General Hospital · 86d
Cleared Jun 05, 2026
Vial Adapter
K260301 · LHI
Hangzhou Qiantang Longyue...
General Hospital · 126d
Cleared Jun 05, 2026
Temperature probes (T2252-PG)
K253162 · FLL
Unimed Medical Supplies, Inc.
General Hospital · 252d
Cleared Jun 04, 2026
Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
K252575 · FYA
New York Embroidery Studio (NYES)
General Hospital · 294d
Cleared Jun 03, 2026
Nitrile Disposable Examination Gloves
K260806 · LZA
Vista Industries,, LLC
General Hospital · 83d
Cleared Jun 03, 2026
Straumann® ProClean™ Cassette (041.800
K260726 · KCT
Institut Straumann AG
General Hospital · 90d
Cleared Jun 03, 2026
Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy...
K260703 · LZA
S&S Glove Corporation
General Hospital · 91d
Cleared Jun 03, 2026
SteriTite Container System with MediTray Products
K252854 · KCT
Case Medical, Inc.
General Hospital · 268d
Cleared Jun 02, 2026
Female Culture Device
K252899 · JKA
Zhejiang Kindly Medical Device Co., Ltd.
General Hospital · 264d
Cleared May 28, 2026
Dukal Crepe Paper Sterilization Wrap
K252823 · FRG
Dukal, LLC
General Hospital · 266d
Cleared May 22, 2026
Guanhong Sharps Container (GHW-1F1)
K253773 · MMK
Taizhou Huangyan Guanhong Plastic...
General Hospital · 177d
Cleared May 22, 2026
Sterile Latex Powder Free Surgical Gloves
K253060 · KGO
Protect Gloves Company Limited
General Hospital · 242d