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

1–24 of 17,791

Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital

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Cleared Aug 26, 2026

Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns...

Principle & Will Co., Ltd.

General Hospital · 198d

Cleared Aug 25, 2026

Promisemed X-Safety Pen Needle

Promisemed Hangzhou Meditech Co., Ltd.

General Hospital · 91d

Cleared Aug 25, 2026

SOL-M Luer Lock Syringe with Exchangeable Needle Tray

Sol-Millennium Medical, Inc.

General Hospital · 410d

Not Cleared Aug 19, 2026

Aletta® Autonomous Robotic Phlebotomy Device (ARPD™) (Gen1 US)

DEN250046 · SIW

General Hospital · 327d

Cleared Aug 18, 2026

NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE...

Kossan International Sdn Bhd

General Hospital · 160d

Cleared Aug 14, 2026

Disposable Pen Injector (KXYC-03C02, KXYC-03A03)

Jiangsu Enjosim Medical Technology...

General Hospital · 262d

Cleared Aug 11, 2026

VR® Personal Protective Level 4 Gown (VR Gowns)

PolyConversions, Inc.

General Hospital · 130d

Cleared Aug 10, 2026

Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type...

Hh Global Technology, Inc.

General Hospital · 25d

Cleared Aug 10, 2026

Unimpregnated Central Venous Catheter

Spectrum Vascular

General Hospital · 202d

Cleared Aug 07, 2026

Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)

Yadu Medical (Henan) Co., Ltd.

General Hospital · 130d

Cleared Aug 07, 2026

Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R,...

Hangzhou Qiantang Longyue...

General Hospital · 140d

Cleared Aug 05, 2026

Huahong Sharps Container (HHR-I, HHR-II)

Tianjin Huahong Technology Co., Ltd.

General Hospital · 142d

Cleared Aug 03, 2026

VueJect® Ultrasound Enhancing Agent Delivery System

Acist Medical Systems, Inc.

General Hospital · 41d

Cleared Jul 29, 2026

Profoject™ Dual-Safety Pen Needles

CMT Health PTE., Ltd.

General Hospital · 57d

Cleared Jul 28, 2026

Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and...

Hartalega NGC Sdn. Bhd.

General Hospital · 159d

Cleared Jul 28, 2026

Giraffe™ OmniBed™ Carestation (CS1)

Datex-Ohmeda, Inc.

General Hospital · 179d

Cleared Jul 24, 2026

RemunityPRO+ Pump for Remodulin® (treprostinil) Injection

General Hospital · 242d

Cleared Jul 21, 2026

PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves

O&M Halyard, Inc.

General Hospital · 36d

Cleared Jul 20, 2026

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs...

Hartalega NGC Sdn. Bhd.

General Hospital · 201d

Cleared Jul 15, 2026

Profoject™ Pen Needles (Model A

CMT Health PTE., Ltd.

General Hospital · 131d

Cleared Jul 13, 2026

Ultra-Fine™ SAFETY Insulin Syringe

embecta Medical II, LLC

General Hospital · 171d

Cleared Jul 10, 2026

NYES Tuff Cuff L3 Disposable Gowns

New York Embroidery Studio

General Hospital · 29d

Cleared Jul 10, 2026

ClearSafe Closed System

MedSource Labs, LLC

General Hospital · 101d

Cleared Jul 09, 2026

MedSource QuickSafe™ Safety IV Catheter

MedSource Labs, LLC

General Hospital · 142d

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