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
3001–3024 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 08, 2017
Nipro SafeTouch IV Catheter
K161681 · FOZ
Nipro Medical Corporation
General Hospital · 264d
Cleared Mar 07, 2017
iSage Rx (iSage Rx Basal Insulin Titration)
K161865 · NDC
Isag Rx, Inc.
General Hospital · 243d
Cleared Mar 03, 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
K162646 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 162d
Cleared Mar 03, 2017
SREE MRI Transport Incubator
K161918 · FPL
Advanced Imaging Research Dba Sree...
General Hospital · 233d
Cleared Feb 28, 2017
BD Nexiva Diffusics Closed IV Catheter System
K170283 · FOZ
Becton, Dickinson and Company
General Hospital · 29d
Cleared Feb 27, 2017
BD PosiFlush Heparin Lock Flush Syringe
K163591 · NZW
Becton, Dickinson and Company
General Hospital · 69d
Cleared Feb 27, 2017
ComfortGuard Surgical Gown, i600, Film Reinforced
K163191 · FYA
Gri Medical & Electrical Technology...
General Hospital · 105d
Cleared Feb 27, 2017
Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP...
K162982 · LZA
Medline Industries, Inc.
General Hospital · 124d
Cleared Feb 24, 2017
Vesco Medical NRFit Tip Syringes
K170218 · FMF
Vesco Medical, LLC
General Hospital · 30d
Cleared Feb 24, 2017
Arrow Endurance Extended Dwell Peripheral Catheter System
K163513 · FOZ
Arrow International, Inc. (Subsidiary...
General Hospital · 71d
Cleared Feb 24, 2017
DT-100
K160358 · FLL
Mediana Co., Ltd.
General Hospital · 381d
Cleared Feb 23, 2017
Medtronic Transportation/Sterilization Cassettes
K163279 · KCT
Medtronic Sofamor Danek USA, Inc.
General Hospital · 94d
Cleared Feb 23, 2017
Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl...
K163168 · LYZ
Hebei Hongtai Plastic Products...
General Hospital · 101d
Cleared Feb 23, 2017
Family of Steam sterilizers B17 B22 Series
K161848 · FLE
Cefla S.C.
General Hospital · 233d
Cleared Feb 23, 2017
Powder Free Nitrile Examination Gloves, Black
K161099 · LZA
Pt. Maja Agung Latexindo
General Hospital · 310d
Cleared Feb 22, 2017
Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue,...
K163126 · LZA
Blue Sail Medical Co.,Ltd
General Hospital · 106d
Cleared Feb 22, 2017
Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E
K163041 · LZA
Pt. Medisafe Technologies
General Hospital · 114d
Cleared Feb 16, 2017
STERRAD NX Sterilizer
K162007 · MLR
Advanced Sterilization Products
General Hospital · 211d
Cleared Feb 13, 2017
POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs
K163146 · LZC
Hebei Hongsen Plastics Technology Co,...
General Hospital · 96d
Cleared Feb 10, 2017
Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH
K161606 · FMF
Terumo Europe N.V.
General Hospital · 245d
Cleared Feb 10, 2017
SteriTite Containers System & MediTray Products
K161415 · FRG
Case Medical, Inc.
General Hospital · 263d
Cleared Feb 08, 2017
Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove
K162852 · KGO
Lucenxia Prescience AG
General Hospital · 120d
Cleared Feb 08, 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
K162491 · LZA
Hartalega Sdn Bhd
General Hospital · 154d
Cleared Feb 08, 2017
Transformair Indoor Air Purifier
K161468 · FRA
Transformair, LLC
General Hospital · 257d