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
1681–1704 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 21, 2021
Disposable Surgical Gowns
K202532 · FYA
Anhui Medpurest Medical Technology...
General Hospital · 354d
Cleared Aug 20, 2021
Nitrile Exam Gloves, Powder Free, Blue
K211699 · LZA
Hengchang (Dongying) Medical...
General Hospital · 78d
Cleared Aug 20, 2021
Molekule Air Pro
K211194 · FRA
Molekule, Inc.
General Hospital · 121d
Cleared Aug 20, 2021
Latex Examination Glove, Powder free with Protein Content Labeling Claim (50...
K203705 · LYY
Careplus (M) Sdn Bhd
General Hospital · 245d
Cleared Aug 20, 2021
Medical Gloves
K203622 · LZA
Beijing Biosis Healing Biolog Ical...
General Hospital · 252d
Cleared Aug 20, 2021
Powder Free Nitrile Examination Glove Black and Dual Color White-Blue
K201857 · LZA
Careplus (M) Sdn Bhd
General Hospital · 410d
Cleared Aug 19, 2021
Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and...
K211620 · LYY
Shen Wei (Usa), Inc.
General Hospital · 85d
Cleared Aug 19, 2021
WYZ Surgical Mask
K211576 · FXX
Wyz Medical Supplies, LLC
General Hospital · 90d
Cleared Aug 19, 2021
Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask
K211462 · FXX
Xiantao S&J Protective Products Co.,...
General Hospital · 100d
Cleared Aug 19, 2021
Purism Non-Sterile Powder Free Nitrile Examination Gloves
K211319 · LZA
Dezhou Purism Medical Technology Co.,...
General Hospital · 111d
Cleared Aug 19, 2021
Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America...
K211066 · FXX
Homtex, Inc.
General Hospital · 129d
Cleared Aug 19, 2021
Empty EVA Bag
K210749 · KPE
Haemotronic S.P.A.
General Hospital · 160d
Cleared Aug 19, 2021
ECOMA Level 2 Disposable Surgical Mask with Ear Loops
K210698 · FXX
Xianning Eco Medical Articles Co., Ltd.
General Hospital · 164d
Cleared Aug 19, 2021
CiRx (R) Surgical Mask
K210256 · FXX
Ningbo Shun YE Medical Company, Ltd.
General Hospital · 199d
Cleared Aug 18, 2021
Disposable medical surgical mask
K212097 · FXX
Hebei Titans Hongsen Medical...
General Hospital · 43d
Cleared Aug 18, 2021
Surgical Face Mask
K211631 · FXX
Macheng Thimble Technology Investment...
General Hospital · 83d
Cleared Aug 18, 2021
Surgical mask
K211454 · FXX
Jiangsu Xingtong Biotechnology Group...
General Hospital · 100d
Cleared Aug 17, 2021
Disposable Medical Nitrile Gloves
K211708 · LZA
Jiangsu Health-Peace Medical...
General Hospital · 75d
Cleared Aug 16, 2021
Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove
K203236 · LZA
Rhino Health, Inc.
General Hospital · 286d
Cleared Aug 14, 2021
I.V. Administration Set
K210381 · FPA
Bq Plus Medical Co., Ltd.
General Hospital · 186d
Cleared Aug 13, 2021
Powder Free Nitrile Patient Examination Gloves, Blue Color
K211860 · LZA
Anhui Powerguard Technology Co., Ltd.
General Hospital · 58d
Cleared Aug 13, 2021
Insignis Subcutaneous Needle Sets
K202279 · FPA
Innovative Health Sciences, LLC
General Hospital · 367d
Cleared Aug 12, 2021
Disposable Surgical Gown
K210510 · FYA
Shandong Zhushi Pharmaceutical Group...
General Hospital · 171d
Cleared Aug 11, 2021
Surgical mask
K211552 · FXX
Shandong Shengquan New Materials Co.,...
General Hospital · 84d