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
3505–3528 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 24, 2014
HONGYUN POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES
K141878 · LYZ
Tangshan Hongyun Plastic Products...
General Hospital · 166d
Cleared Dec 23, 2014
Instru-Safe Instrument Protection System
K142630 · KCT
Summit Medical, Inc.
General Hospital · 97d
Cleared Dec 23, 2014
KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS
K141479 · LZH
Covidien
General Hospital · 202d
Cleared Dec 22, 2014
Xuanye Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K142771 · LYZ
Xuanhua Metallurgical Industry Co., Ltd.
General Hospital · 88d
Cleared Dec 22, 2014
POWDER FREE NITRILE SURGICAL GLOVES, WHITE COLOR (BRAND NAME: TITANFINE)
K140989 · KGO
Hebei Hongsen Plastics Technology Co,...
General Hospital · 249d
Cleared Dec 22, 2014
EVOTECH ECR
K140977 · FEB
Advanced Sterilization Products
General Hospital · 250d
Cleared Dec 19, 2014
Powder Free Yellow Vinyl Patient Examination Gloves
K142508 · LYZ
Zibo Huaqi Trading Co., Ltd.
General Hospital · 102d
Cleared Dec 19, 2014
Tyvek® Pouch/Roll with STERRAD® Chemical Indicator
K141693 · FRG
Advanced Sterilization Products
General Hospital · 178d
Cleared Dec 19, 2014
ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE...
K133800 · FRA
Hgi Industires
General Hospital · 371d
Cleared Dec 18, 2014
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin...
K142805 · LZA
Hartalega Sdb. Bhd.
General Hospital · 80d
Cleared Dec 18, 2014
Snap Insulin Pump System
K142619 · LZG
Asante Solutions, Inc.
General Hospital · 93d
Cleared Dec 18, 2014
Nitrile Powder Free Examination Glove (Blue)
K142588 · LZA
Hartalega Sdn Bhd
General Hospital · 94d
Cleared Dec 18, 2014
Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue, Pink )
K142570 · LYZ
Ever Light Plastic Products Co., Ltd.
General Hospital · 97d
Cleared Dec 18, 2014
NacrousPowder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K142342 · LYZ
Nacrous Plastic Co., Ltd.
General Hospital · 119d
Cleared Dec 18, 2014
SMART LABEL, PROPOFOL
K142333 · MRZ
American I.V. Products, Inc. Dba Aiv,...
General Hospital · 119d
Cleared Dec 18, 2014
KIMGUARD ONE STEP STERILIZATION WRAP
K141712 · FRG
Halyard Health
General Hospital · 176d
Cleared Dec 18, 2014
BECTON DICKINSON INTELLIPORT SYSTEM
K141474 · PHC
Becton, Dickinson & CO
General Hospital · 198d
Cleared Dec 17, 2014
InFill Graft Delivery System
K143488 · FMF
Pinnacle Spine Group, LLC
General Hospital · 9d
Cleared Dec 17, 2014
Powder Free Vinyl Patient Examination Gloves
K142571 · LYZ
Ever Light Plastic Products Co., Ltd.
General Hospital · 96d
Cleared Dec 17, 2014
STERIZONE CHEMICAL INDICATOR
K141698 · JOJ
Tso3, Inc.
General Hospital · 176d
Cleared Dec 17, 2014
STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR
K141580 · FRC
Tso3, Inc.
General Hospital · 187d
Cleared Dec 17, 2014
STERIZONE STERILIZER
K141163 · PJJ
Tso3, Inc.
General Hospital · 226d
Cleared Dec 16, 2014
FORT DEFIANCE AUTOMATED STEAM STERILIZER
K141009 · FLE
Fort Defiance Industries, Inc.
General Hospital · 242d
Cleared Dec 15, 2014
INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM
K141513 · KCT
Summit Medical, Inc.
General Hospital · 189d