Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: General Hospital ×
17,825 results
1081–1104 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Aug 30, 2022
Medical Surgery Mask, Model:2626-7
K220067 · FXX
Dongguan Missadola Technology Co., Ltd.
General Hospital · 232d
Cleared Aug 30, 2022
SOL-GUARD Safety Pull Button Collection Set
K213718 · JKA
Sol-Millennium Medical, Inc.
General Hospital · 279d
Cleared Aug 30, 2022
Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile...
K212846 · FMF
Jiangsu Jichun Medical Devices Co., Ltd.
General Hospital · 357d
Cleared Aug 30, 2022
Novum IQ Syringe Pump
K211125 · FRN
Baxter Healthcare Corporation
General Hospital · 502d
Cleared Aug 30, 2022
Dose IQ Safety Software
K211124 · PHC
Baxter Healthcare Corporation
General Hospital · 502d
Cleared Aug 29, 2022
K-SHIELD Zen
K220799 · JKA
Sb-Kawasumi Laboratories, Inc.
General Hospital · 164d
Cleared Aug 29, 2022
Leaderflex Mini and Leaderflex Nano
K212370 · FOZ
Vygon USA
General Hospital · 395d
Cleared Aug 27, 2022
Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy...
K222449 · LZC
Better Care Plastic Technology Co., Ltd.
General Hospital · 12d
Cleared Aug 25, 2022
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization...
K222543 · NVE
Steris
General Hospital · 3d
Cleared Aug 25, 2022
Iconic Latex Glove
K221648 · LYY
Iconic Medicare Sdn Bhd
General Hospital · 79d
Cleared Aug 25, 2022
Nitrile Exam Gloves (Blue, Black)
K221143 · LZA
Hebei Astro Medical Supply Co., Ltd.
General Hospital · 127d
Cleared Aug 25, 2022
Disposable, vinyl examination gloves, Yellow
K220055 · LYZ
Dezhou Hengchang Medical Technology...
General Hospital · 231d
Cleared Aug 24, 2022
Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly
K222232 · LJS
Bard Access Systems, Inc.
General Hospital · 30d
Cleared Aug 24, 2022
ivWatch Model 400
K222212 · PMS
Ivwatch, LLC
General Hospital · 30d