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
1561–1584 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 29, 2021
Enbio S
K210279 · FLE
Enbio Group AG
General Hospital · 270d
Cleared Oct 29, 2021
Phoenix Digital Thermometer
K201032 · FLL
Phoenix Innovative Healthcare...
General Hospital · 557d
Cleared Oct 28, 2021
AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers
K212424 · FLE
STERIS Corporation
General Hospital · 85d
Cleared Oct 28, 2021
Examination gloves -Type C (Nitrile gloves)
K212290 · LZA
Jiangxi Kemei Medical Apparatus &...
General Hospital · 99d
Cleared Oct 28, 2021
Disposable Nitrile Examination Gloves (Powder free, Blue)
K211581 · LZA
Leping Shengde Medical Technology...
General Hospital · 160d
Cleared Oct 27, 2021
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with...
K211604 · LZA
Shanxi Hongjin Plastic Technology...
General Hospital · 155d
Cleared Oct 26, 2021
Disposable Medical Nitrile Examination Gloves
K212363 · LZA
Lanhuo Medical Technology (Jiangsu)...
General Hospital · 88d
Cleared Oct 25, 2021
Introcan Safety 3 Closed IV Catheter
K213085 · FOZ
B.Braun Medical, Inc.
General Hospital · 31d
Cleared Oct 25, 2021
Disposable Nitrile Examination Glove
K212401 · LZA
Inner Mongolia Cureguard Medical...
General Hospital · 84d
Cleared Oct 25, 2021
Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)
K212293 · FXX
Jiangmen Ningrui Medical Supplies...
General Hospital · 95d
Cleared Oct 25, 2021
Best Glove-Nitrile Powder Free Examination Glove
K210249 · LZA
Bestsafe Glove Co., Ltd.
General Hospital · 269d
Cleared Oct 24, 2021
Surgical Face Mask
K212368 · FXX
Anhui Tiankang Medical Technology...
General Hospital · 86d
Cleared Oct 24, 2021
Vinyl Examination Gloves(Yellow)
K211698 · LYZ
Liuping Trading Co., Ltd.
General Hospital · 143d
Cleared Oct 24, 2021
Surgical Gown
K211509 · FYA
Hubei Wanli Protective Products Co.,...
General Hospital · 163d
Cleared Oct 24, 2021
Disposable Medical Surgical Mask
K210348 · FXX
Weihai Dishang Medical Technology...
General Hospital · 258d
Cleared Oct 22, 2021
UroLift System Rigid Retrieval Kit Sterilization Tray
K212396 · KCT
Neotract, Inc.
General Hospital · 81d
Cleared Oct 22, 2021
STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette
K212200 · MLR
Plasmapp Co,., Ltd.
General Hospital · 100d
Cleared Oct 22, 2021
Tyvek(R) Roll with CI for STERLINKTM Sterilizer
K212198 · FRG
Plasmapp Co,., Ltd.
General Hospital · 100d
Cleared Oct 22, 2021
Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators...
K212193 · FRC
Plasmapp Co,., Ltd.
General Hospital · 100d
Cleared Oct 21, 2021
Medical Examination Gloves
K212311 · LZA
Guangzhou Junda Gloves Co., Ltd.
General Hospital · 90d
Cleared Oct 19, 2021
Sterile High-pressure Angiographic Syringes for Single-use
K211564 · DXT
Shenzhen Boon Medical Supply Co., Ltd.
General Hospital · 152d
Cleared Oct 19, 2021
Nitrile Examination Gloves
K210706 · LZA
Niujian Technology Co., Ltd.
General Hospital · 223d
Cleared Oct 19, 2021
Surgical 3D Mask
K203565 · FXX
Inno Lifecare
General Hospital · 316d
Cleared Oct 18, 2021
Surgical Gown
K211809 · FYA
Wuhan Dymex Healthcare Co., Ltd.
General Hospital · 129d