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
2473–2496 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 12, 2019
Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet...
K182640 · LZA
Shandong Hengya Packaging Printing...
General Hospital · 200d
Cleared Apr 10, 2019
Oryum and Ovem Epidermal Deri Prick Test Applicator
K182582 · SCL
Allergy & Applicator Depot, LLC
General Hospital · 203d
Cleared Apr 09, 2019
Adult Intraosseous Infusion Device
K182770 · FMI
Einstein Works, LLC
General Hospital · 193d
Cleared Apr 05, 2019
V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature...
K190103 · MLR
STERIS Corporation
General Hospital · 73d
Cleared Apr 05, 2019
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile,...
K183287 · LZA
Kossan International Sdn Bhd
General Hospital · 130d
Cleared Apr 05, 2019
EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)
K182268 · FMF
Flat Medical Co., Ltd.
General Hospital · 227d
Cleared Apr 04, 2019
HIgH-Flo Super26 Subcutaneous Needle Sets
K180843 · FPA
Repro-Med Systems, Inc. Dba Rms...
General Hospital · 367d
Cleared Apr 03, 2019
Infrared thermometer
K182597 · FLL
Shenzhen Pango Electronic Co., Ltd.
General Hospital · 195d
Cleared Mar 28, 2019
Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use...
K182176 · KGO
Pt. Medisafe Technologies
General Hospital · 230d
Cleared Mar 27, 2019
Tyto Thermometer
K190242 · FLL
Tyto Care , Ltd.
General Hospital · 49d
Cleared Mar 27, 2019
AMSCO 600 Steam Sterilizer
K183410 · FLE
STERIS Corporation
General Hospital · 107d
Cleared Mar 26, 2019
Velano Vascular Q2 Extension Set
K182897 · FPA
Velano Vascular
General Hospital · 161d
Cleared Mar 22, 2019
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid...
K190104 · MED
Steris Corporations
General Hospital · 59d
Cleared Mar 22, 2019
Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs
K182948 · KGO
Ansell Healthcare Products, LLC
General Hospital · 150d
Cleared Mar 22, 2019
Powder Free Nitrile Examination Gloves, Blue, Tested for Use with...
K182554 · LZA
He Chuang Plastic & Rubber Co., Ltd.
General Hospital · 186d
Cleared Mar 22, 2019
HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)
K181959 · FRG
Owens & Minor Halyard, Inc.
General Hospital · 242d
Cleared Mar 22, 2019
ON-Q* Pump with Bolus
K181360 · MEB
Halyard Health
General Hospital · 304d
Cleared Mar 20, 2019
BD Nexiva Closed IV Catheter System
K183399 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 103d
Cleared Mar 19, 2019
Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy...
K182383 · LZC
Yty Industry (Manjung) Sdn Bhd
General Hospital · 200d
Cleared Mar 15, 2019
nextaro Transfer System, nextaro va
K183187 · LHI
Sfm Medical Devices GmbH
General Hospital · 116d
Cleared Mar 15, 2019
TCAT (R) THA Instrument Tray Set
K180127 · KCT
THINK Surgical, Inc.
General Hospital · 422d
Cleared Mar 14, 2019
BD Plastipak Syringe
K182589 · FMF
Becton, Dickinson and Company
General Hospital · 175d
Cleared Mar 12, 2019
Safety insulin needle for single use
K181447 · FMI
Berpu Medical Technology Co., Ltd.
General Hospital · 284d
Cleared Mar 11, 2019
Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with...
K182241 · LZA
Sri Trang Gloves (Thailand) Co., Ltd.
General Hospital · 203d