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
1537–1560 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 09, 2021
Surgical Face Mask
K212526 · FXX
Suzhou Janee Medical Technology Co.,...
General Hospital · 90d
Cleared Nov 09, 2021
FreedomEdge(R) Syringe Infusion System
K211206 · FRN
Repro-Medical System, Inc., Dba Koru...
General Hospital · 201d
Cleared Nov 09, 2021
Medical Face Masks, Model Name:MY020003
K211165 · FXX
Huizhou Jie Bai Purification Co., Ltd.
General Hospital · 204d
Cleared Nov 08, 2021
Biotech Dental Kits
K212068 · KCT
Biotech Dental, Sas
General Hospital · 129d
Cleared Nov 07, 2021
Medical Examination Gloves (Tested for Use with Chemotherapy)
K212506 · LZA
Guangdong Gymda Medical Technology...
General Hospital · 90d
Cleared Nov 07, 2021
Isolation Gown AAMI Level 3
K212504 · FYC
Kenpax International Limited
General Hospital · 90d
Cleared Nov 05, 2021
Nitrile Examination Gloves
K212551 · LZA
Anhui Fine Glove Medical Technology...
General Hospital · 84d
Cleared Nov 05, 2021
Disposable Nitrile Examination gloves
K212485 · LZA
Fujian Yuanxin Safety Protection...
General Hospital · 88d
Cleared Nov 05, 2021
Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))
K212460 · FXX
Guangzhou Zhengkang Medical Equipment...
General Hospital · 92d
Cleared Nov 05, 2021
Best Glove-Latex Powder Free Examination Glove
K210253 · LYY
Bestsafe Glove Co., Ltd.
General Hospital · 280d
Cleared Nov 05, 2021
Disposable Medical Face Mask
K202676 · FXX
Zhejiang Senhong Medical&Instrument...
General Hospital · 416d
Cleared Nov 04, 2021
Medical Face Mask
K212471 · FXX
Haian Medigauze Co., Ltd.
General Hospital · 90d
Cleared Nov 04, 2021
Disposable Nitrile Examination Glove
K212467 · LZA
Inner Mongolia Boming Medical...
General Hospital · 90d
Cleared Nov 04, 2021
Blood Collection Needle for Single Use & Blood Collection Needle with Holder...
K212019 · JKA
Jiangsu Micsafe Medical Technology...
General Hospital · 129d
Cleared Nov 04, 2021
Powder Free Vinyl Examination Gloves
K211103 · LYZ
Shanghai Shengda Medical Applications...
General Hospital · 205d
Cleared Nov 03, 2021
S.I.N. Instrument Kits
K212404 · KCT
S.I.N. ? Sistema DE Implante Nacional...
General Hospital · 93d
Cleared Nov 03, 2021
Nulife
K210969 · KGO
Mrk Healthcare Pvt, Ltd.
General Hospital · 217d
Cleared Nov 03, 2021
SOL-CARE IV Bag Safety Connector
K202732 · LHI
Sol-Millennium Medical Group
General Hospital · 411d
Cleared Nov 02, 2021
Powder Free Nitrile Patient Examination Gloves, Blue Color
K210777 · LZA
Shandong Jieshi Medical Products Co.,...
General Hospital · 232d
Cleared Nov 02, 2021
Disposable Medical Mask
K210222 · FXX
Guangdong Lide Medical Technology...
General Hospital · 278d
Cleared Nov 01, 2021
SterileRight sterilization pouch and roll
K212338 · FRG
Sterileright Packaging Mfg., Inc.
General Hospital · 97d
Cleared Nov 01, 2021
Nitrile Examination Gloves (Blue, Violet)
K211586 · LZA
Lyncmed Medical Technology (Beijing)...
General Hospital · 161d
Cleared Oct 31, 2021
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
K210588 · LZA
Onetexx Sdn Bhd
General Hospital · 247d
Cleared Oct 29, 2021
SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue...
K212308 · LZA
Srirungruang Global Co., Ltd.
General Hospital · 98d