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
1585–1608 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 18, 2021
Hypodermic Safety Needle
K211555 · MEG
Anhui Hongyu Wuzhou Medical...
General Hospital · 152d
Cleared Oct 14, 2021
Medical Protective Masks
K212205 · FXX
Qinhuangdao Taizhi Medical Technology...
General Hospital · 91d
Cleared Oct 14, 2021
Nitrile Patient Examination Gloves
K211914 · LZA
Yingxiang Glove Products Co., Ltd.
General Hospital · 115d
Cleared Oct 14, 2021
Sterile Syringe With Safety Needle
K211753 · MEG
Jiangxi Hongda Medical Equipment...
General Hospital · 129d
Cleared Oct 14, 2021
Sterile Hypodermic Needles for Single Use
K211214 · FMI
Azur Medical Company, Inc.
General Hospital · 174d
Cleared Oct 14, 2021
Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special...
K211121 · PTI
Intera Oncology, Inc.
General Hospital · 182d
Cleared Oct 13, 2021
MiniLoad Syringe
K212544 · FMF
Ocuject, LLC
General Hospital · 62d
Cleared Oct 13, 2021
Medical Nitrile Examination Gloves
K212014 · LZA
Jiangxi Ronglai Medical Technology...
General Hospital · 107d
Cleared Oct 13, 2021
Proclean - Nitrile Powder Free Examination Gloves
K211374 · LZA
Dr.Boo Company Limited
General Hospital · 162d
Cleared Oct 12, 2021
Nitrile examination gloves
K211927 · LZA
Fitone Latex Products Co., Ltd....
General Hospital · 112d
Cleared Oct 12, 2021
Disposable Surgical Mask (Model: YYKZ-01)
K210845 · FXX
Jiaxing Amazing Travel-Ware Co., Ltd.
General Hospital · 204d
Cleared Oct 10, 2021
Child Face Mask
K201514 · OXZ
Shandong Shengquan New Material Co.,...
General Hospital · 489d
Cleared Oct 09, 2021
STERRAD 100NX Sterilizer with ALLClear Technology
K212174 · MLR
Advanced Sterilization Products, Inc.
General Hospital · 89d
Cleared Oct 08, 2021
Medical Examination Gloves
K212078 · LZA
Guangdong Gymda Medical Technology...
General Hospital · 98d
Cleared Oct 08, 2021
Medical Surgical Mask
K210813 · FXX
Sichuan Pharmaceutical., Inc.
General Hospital · 205d
Cleared Oct 08, 2021
Single-Use Medical Face Mask
K210622 · FXX
Jiangxi Hongda Medical Equipment...
General Hospital · 220d
Cleared Oct 08, 2021
Infrared Thermometer (Model K9)
K203497 · FLL
Kangzhan Communication Electronics...
General Hospital · 315d
Cleared Oct 07, 2021
Sterile syringes for single use with/without needle
K211211 · FMF
Azur Medical Company, Inc.
General Hospital · 167d
Cleared Oct 07, 2021
Surgical Gown
K211077 · FYA
Wujiang Tutaike Textiles & Finishing...
General Hospital · 178d
Cleared Oct 06, 2021
ZinRom Nitrile examination gloves
K211719 · LZA
Changzhou Xingrong Medical Technology...
General Hospital · 124d
Cleared Oct 06, 2021
Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)
K211621 · KGO
Careplus (M) Sdn Bhd
General Hospital · 133d
Cleared Oct 05, 2021
Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs
K212036 · LZA
Jiangsu Yanfang Medical Technology...
General Hospital · 97d
Cleared Oct 05, 2021
Sterile hypodermic syringes for single use
K211728 · FMF
Jiangsu Kangyou Medical Instrument...
General Hospital · 123d
Cleared Oct 04, 2021
Surgical Face Mask
K211899 · FXX
Hubei Yi-Ya Protective Products Co.,...
General Hospital · 105d