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
4609–4632 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 20, 2010
SYNTHETIC, POWDER-FREE NITRILE EXAMINATION
K102593 · LYZ
Zibo Yinghao Medical Products Co., Ltd.
General Hospital · 102d
Cleared Dec 20, 2010
SUNMAX VIETNAM CO. LTD POWDER FREE WHITE NITRILE EXAMINATION GLOVE
K101870 · LZA
Sunmax Vietnam Co., Ltd.
General Hospital · 167d
Cleared Dec 17, 2010
HIGH PRESSURE SETS-400 PSI
K100576 · FPA
Icu Medical, Inc.
General Hospital · 291d
Cleared Dec 16, 2010
IBED WIRELESS WITH IBED AWARENESS
K103536 · FNL
Stryker Corporation
General Hospital · 15d
Cleared Dec 16, 2010
NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE...
K103249 · LZA
Cardinal Health, Inc.
General Hospital · 43d
Cleared Dec 13, 2010
POWDERED VINYL PATIENT EXAMINIATION GLOVES, CLEAR (NON-COLORED)
K102976 · LYZ
Heze Juxinyuan Food Co., Ltd.
General Hospital · 68d
Cleared Dec 13, 2010
DIGITAL THERMOMETER
K102718 · FLL
International Regulatory Consultants,...
General Hospital · 83d
Cleared Dec 10, 2010
INFUSION SETS
K103344 · FPA
Hospira, Inc.
General Hospital · 25d
Cleared Dec 10, 2010
RII INFRARED EAR THERMOMETER,
K102187 · FLL
Radiant Innovation, Inc.
General Hospital · 129d
Cleared Dec 08, 2010
3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M...
K101910 · FRC
3M Company
General Hospital · 152d
Cleared Dec 07, 2010
SKELETAL DYNAMICS STERILIZATION TRAYS
K102103 · KCT
Skeletal Dynamics, LLC
General Hospital · 133d
Cleared Dec 07, 2010
AIDERA DIASEND SYSTEM
K101806 · MRZ
Aidera AB
General Hospital · 162d
Cleared Dec 03, 2010
RELIANCE ENDOSCOPE PROCESSING SYSTEM
K102244 · NZA
STERIS Corporation
General Hospital · 116d
Cleared Dec 03, 2010
SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS
K101224 · DWL
Griffiths and Nielsen, Ltd.
General Hospital · 214d
Cleared Dec 01, 2010
V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40
K100504 · LZG
Valeritas, LLC
General Hospital · 282d
Cleared Nov 29, 2010
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW...
K102790 · LZC
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 63d
Cleared Nov 23, 2010
CLICKFINE PEN NEEDLE
K102108 · FMI
Ypsomed AG
General Hospital · 119d
Cleared Nov 23, 2010
BIOGEL ORTHOPRO INDICATOR UNDERGLOVE
K101163 · KGO
Molnlycke Health Care USA
General Hospital · 211d
Cleared Nov 22, 2010
POWDERFREE BLACK NITRILE EXAMINATION GLOVES
K102620 · LZA
Pt. Medisafe Technologies
General Hospital · 70d
Cleared Nov 22, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K102444 · LYZ
Zibo Yingbo Medical Products, Inc.
General Hospital · 88d
Cleared Nov 22, 2010
SYSTEM 1E CHEMICAL INDICATOR
K102217 · JOJ
STERIS Corporation
General Hospital · 108d
Cleared Nov 22, 2010
SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428
K102122 · KCT
Smith & Nephew, Inc.
General Hospital · 116d
Cleared Nov 22, 2010
HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET)
K101547 · FMF
Henke-Sass, Wolf GmbH
General Hospital · 172d
Cleared Nov 19, 2010
BARRIER N95 PARTICULATE RESPIRATOR
K102923 · MSH
Molnlycke Health Care
General Hospital · 49d