FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,778 results
1–24 of 17,778
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 29, 2026
Profoject™ Dual-Safety Pen Needles
K261829 · FMI
CMT Health PTE., Ltd.
General Hospital · 57d
Cleared Jul 28, 2026
Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and...
K260558 · KGO
Hartalega NGC Sdn. Bhd.
General Hospital · 159d
Cleared Jul 28, 2026
Giraffe™ OmniBed™ Carestation (CS1)
K260326 · FMZ
Datex-Ohmeda, Inc.
General Hospital · 179d
Cleared Jul 24, 2026
RemunityPRO+ Pump for Remodulin® (treprostinil) Injection
K253703 · FRN
Deka R&D Corp
General Hospital · 242d
Cleared Jul 21, 2026
PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves
K262014 · LZA
O&M Halyard, Inc.
General Hospital · 36d
Cleared Jul 20, 2026
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs...
K254285 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 201d
Cleared Jul 15, 2026
Profoject™ Pen Needles (Model A
K260739 · FMI
CMT Health PTE., Ltd.
General Hospital · 131d
Cleared Jul 13, 2026
Ultra-Fine™ SAFETY Insulin Syringe
K260208 · FMF
embecta Medical II, LLC
General Hospital · 171d
Cleared Jul 10, 2026
NYES Tuff Cuff L3 Disposable Gowns
K261949 · FYA
New York Embroidery Studio
General Hospital · 29d
Cleared Jul 10, 2026
ClearSafe Closed System
K261041 · FOZ
MedSource Labs, LLC
General Hospital · 101d
Cleared Jul 09, 2026
MedSource QuickSafe™ Safety IV Catheter
K260539 · FOZ
MedSource Labs, LLC
General Hospital · 142d
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