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
1033–1056 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 19, 2022
Promisemed X-Safety Pen Needle
K220129 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 244d
Cleared Sep 19, 2022
Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe
K213013 · QNQ
Jeil Tech Co., Ltd.
General Hospital · 364d
Cleared Sep 16, 2022
Surgical Face Masks (Ear Loops And Tie-On)
K221534 · FXX
San-M Package Co., Ltd.
General Hospital · 112d
Cleared Sep 16, 2022
AllureTM Surgical Mask
K212926 · FXX
Allure Gift Wraps Private Limited
General Hospital · 367d
Cleared Sep 16, 2022
Tempo Smart Button
K212217 · QOG
Eli Lilly and Company
General Hospital · 427d
Cleared Sep 15, 2022
Nitrile Patient Examination Gloves, Powder Free
K220697 · LZA
Lalan Rubbers (Pvt), Ltd.
General Hospital · 190d
Cleared Sep 15, 2022
SafePort(TM) Manifold (or Stopcock)
K211204 · FMG
Elcam Medical Acal
General Hospital · 511d
Cleared Sep 14, 2022
Qorda QD1
K220990 · FRF
Winix, Inc.
General Hospital · 163d
Cleared Sep 13, 2022
Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves
K221748 · KGO
Guilin Hbm Health Protections, Inc.
General Hospital · 89d
Cleared Sep 13, 2022
LAITEST Medical Face Mask
K214035 · FXX
R&R Medical Corporation, Ltd.
General Hospital · 264d
Cleared Sep 13, 2022
MagiCath II
K210929 · FOZ
Woo Young Medical Co., Ltd.
General Hospital · 533d
Cleared Sep 12, 2022
Infrared Forehead Thermometer
K220084 · FLL
Qingdao Yasee Medical Device Co., Ltd.
General Hospital · 245d
Cleared Sep 09, 2022
Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE...
K222440 · FRG
Steris
General Hospital · 28d
Cleared Sep 09, 2022
V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature...
K222093 · MLR
Steris
General Hospital · 56d
Cleared Sep 09, 2022
PointCore Surgical Mask
K220944 · FXX
Pointcore, Inc.
General Hospital · 162d
Cleared Sep 09, 2022
Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple,...
K220859 · LZA
Careglove Global Sdn. Bhd.
General Hospital · 169d
Cleared Sep 06, 2022
Spectrum IQ Infusion System with Dose IQ Safety Software
K222048 · FRN
Baxter Healthcare Corporation
General Hospital · 56d
Cleared Sep 02, 2022
Perfetta Moderate Medical Face Mask
K222426 · FXX
Phu Bao Group Company Limited
General Hospital · 22d
Cleared Sep 02, 2022
Savewo ClassicMASK
K221957 · FXX
Savewo Limited
General Hospital · 59d
Cleared Sep 02, 2022
Arrow Pressure Injectable Midline Catheter
K213855 · PND
Arrow International, LLC Subsidiary...
General Hospital · 266d
Cleared Sep 01, 2022
Disposable Medical Masks
K221038 · FXX
Hantech Medical Device Co., Ltd.
General Hospital · 147d
Cleared Aug 31, 2022
Vented Vial Adapter 20mm
K213513 · LHI
West Pharma Services Il, Ltd.
General Hospital · 302d
Cleared Aug 30, 2022
Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use...
K221164 · LZA
Hong Seng Gloves Sdn Bhd
General Hospital · 130d
Cleared Aug 30, 2022
JR Medic
K221157 · LZC
Jr Engineering & Medical Technologies...
General Hospital · 131d