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
625–648 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 31, 2023
Ultravision2™ System Integrated Monopolar L-Hook (H/S)™
K231298 · PQM
Alesi Surgical, Ltd.
General Hospital · 180d
Cleared Oct 31, 2023
Ultravision2™ System
K231238 · PQM
Alesi Surgical, Ltd.
General Hospital · 186d
Cleared Oct 31, 2023
SAFIRA
K230083 · FRN
Medovate Limited
General Hospital · 293d
Cleared Oct 30, 2023
Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl
K231029 · LZA
Zhonghong Pulin Medical Products Co.,...
General Hospital · 202d
Cleared Oct 27, 2023
Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)
K233187 · JOJ
Steris
General Hospital · 29d
Cleared Oct 27, 2023
Shina Syringe
K231165 · MEG
Shina Med Corporation
General Hospital · 185d
Cleared Oct 27, 2023
Safety butterfly type blood collection needle, Butterfly type blood...
K213146 · JKA
Jiangsu Rongye Technology Co., Ltd.
General Hospital · 760d
Cleared Oct 26, 2023
Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs,...
K230662 · LZA
Zhonghong Pulin Medical Products Co.,...
General Hospital · 230d
Cleared Oct 25, 2023
BeneHold™ Surgical Incise Drape with CHG antimicrobial II
K230645 · KKX
Avery Dennison Medical , Ltd.
General Hospital · 231d
Cleared Oct 23, 2023
Vesco Q™ Enteral Feeding Pump
K232205 · LZH
Vesco Medical, LLC
General Hospital · 90d
Cleared Oct 20, 2023
V-PRO maX 2 Low Temperature Sterilization System
K233065 · MLR
Steris
General Hospital · 24d
Cleared Oct 20, 2023
Nitrile Examination Gloves, Dual Color Black-Blue
K232550 · LZA
Shanxi Hongjin Plastic Technology...
General Hospital · 58d
Cleared Oct 20, 2023
GAMMEX PI Hybrid Micro (340002055)
K231902 · KGO
Ansell Healthcare
General Hospital · 114d
Cleared Oct 18, 2023
Medline Safety Insulin and TB Syringes
K231907 · MEG
Medline Industries, LP
General Hospital · 111d
Cleared Oct 18, 2023
Terumo Injection Filter Needle (NF-3013RBKE05M)
K230951 · QYM
Terumo Europe N.V.
General Hospital · 197d
Cleared Oct 17, 2023
ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
K222214 · FXY
Thi Total Healthcare Innovation GmbH
General Hospital · 449d
Cleared Oct 14, 2023
Infrared Thermometer (AOJ-20A)
K232128 · FLL
Shenzhen AOJ Medical Technology Co.,...
General Hospital · 89d
Cleared Oct 12, 2023
Skypro, Surgical Gown 6021
K230707 · FYA
Skypro Medical Supplies Company
General Hospital · 212d
Cleared Oct 11, 2023
Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy...
K232070 · LZA
Better Care Plastic Technology Co., Ltd.
General Hospital · 91d
Cleared Oct 06, 2023
Vial Adapter
K232055 · LHI
Shanghai Lingfu Technology Co., Ltd.
General Hospital · 87d
Cleared Oct 06, 2023
Patient Examination Gloves
K230777 · LZA
3A Glove Sdn. Bhd.
General Hospital · 199d
Cleared Oct 06, 2023
Disposable Sterile Syringe
K221777 · FMF
Weihai Shengjie Medical Technology...
General Hospital · 472d
Cleared Oct 05, 2023
MESORAM® Hypodermic Needle (710301)
K230070 · FMI
Promamedical, Inc.
General Hospital · 268d
Cleared Oct 04, 2023
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with...
K231567 · LZA
Better Care Plastic Technology Co., Ltd.
General Hospital · 126d