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
937–960 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 17, 2022
Blood Administration Sets
K220558 · BRZ
Baxter Healthcare Corporation
General Hospital · 262d
Cleared Nov 16, 2022
Disposable surgical face mask
K220302 · FXX
Shandong Aida Medical Products Co., Ltd.
General Hospital · 287d
Cleared Nov 16, 2022
Surgical Gown
K212812 · FYA
Xianning Marveldas Protective...
General Hospital · 439d
Cleared Nov 16, 2022
KNH Surgical Face Mask
K203528 · FXX
Knh Surgical Face Mask
General Hospital · 714d
Cleared Nov 14, 2022
High Fluid-Resistant Surgical and Procedure Mask
K222749 · FXX
America?S Supply Chains
General Hospital · 63d
Cleared Nov 14, 2022
Surgical Face Mask
K222529 · FXX
Xiantao Rayxin Medical Products Co.,...
General Hospital · 84d
Cleared Nov 14, 2022
Standard Surgical Gown (AAMI Level 2)
K222480 · FYA
Foshan Nanhai Plus Medical Co, Ltd.
General Hospital · 89d
Cleared Nov 12, 2022
Nitrile Examination Gloves
K213981 · LZA
Emerald Glove Manufacturing Sdn Bhd
General Hospital · 327d
Cleared Nov 11, 2022
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
K222225 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 109d
Cleared Nov 10, 2022
BD Intraosseous Vascular Access System EMS Powered Driver (D001003)
K223198 · MHC
Bard Access Systems
General Hospital · 28d
Cleared Nov 10, 2022
Humask Pro Vision, Humask Pro Vision 3000
K222551 · FXX
Entreprise Premont, Inc.
General Hospital · 79d
Cleared Nov 10, 2022
Bodygard SFS Surgical Gown Level 4
K221139 · FYA
Feliks Plastik Laminasyon VE Ambalaj...
General Hospital · 205d
Cleared Nov 10, 2022
AMSure Enteral Feeding Pump
K220230 · LZH
Amsino International, Inc.
General Hospital · 287d
Cleared Nov 07, 2022
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
K222898 · LZA
Safesource Direct, LLC
General Hospital · 45d
Cleared Nov 04, 2022
Disposable Medical Face Mask (DF3-001)
K222697 · FXX
Wellmed Dental Medical Supply Co., Ltd.
General Hospital · 58d
Cleared Nov 04, 2022
Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle
K222124 · FMI
Anhui Hongyu Wuzhou Medical...
General Hospital · 109d
Cleared Nov 04, 2022
Medwell Technology Ltd Syringes, various sizes
K212764 · FMF
Medwell Technology, Ltd.
General Hospital · 430d
Cleared Nov 03, 2022
NP Medical nCompass Extension Set with Stabilizing Base
K221518 · FPA
Np Medical
General Hospital · 162d
Cleared Nov 03, 2022
Insulin Syringes without needle
K221045 · FMF
Berpu Medical Technology Co., Ltd.
General Hospital · 209d
Cleared Nov 02, 2022
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with...
K223320 · LZA
Lingshi Hongruida Health Protection...
General Hospital · 5d
Cleared Nov 02, 2022
Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded...
K220371 · LZA
Summit Glove, Inc.
General Hospital · 266d
Cleared Nov 02, 2022
Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for...
K211816 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 509d
Cleared Nov 01, 2022
POSE™ Health Care Surgical Mask
K223270 · FXX
America?S Supply Chains
General Hospital · 8d
Cleared Nov 01, 2022
3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248
K222508 · JOJ
3M Company
General Hospital · 75d