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
4537–4560 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 15, 2011
ALLERGEAZE R CLEAR
K103409 · KXF
Smartpractice
General Hospital · 113d
Cleared Mar 15, 2011
SINGLE CANNULA EXTENDED APPLICATOR
K102563 · KYZ
Micromedics, Inc.
General Hospital · 189d
Cleared Mar 11, 2011
SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR,...
K102692 · FYA
Hangzhou Jincheng Medical Supplier...
General Hospital · 172d
Cleared Mar 10, 2011
VERIFY 270FP CHALLENGE PACK
K103053 · JOJ
STERIS Corporation
General Hospital · 146d
Cleared Mar 04, 2011
STERRAD 100NX STERILIZER EXPRESS CYCLE
K092622 · MLR
Advanced Sterilization Products
General Hospital · 555d
Cleared Mar 03, 2011
TROPHON CHEMICAL INDICATOR
K103126 · JOJ
Nanosonics Limited
General Hospital · 132d
Cleared Mar 03, 2011
AVITA SCANEO IR THERMOMETER MODEL TS4X SERIES
K102554 · FLL
Avita Corporation
General Hospital · 177d
Cleared Mar 03, 2011
NON-STERILE, BLUE & WHITE POWDERED NITRILE EXAMINATION GLOVES
K101820 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 246d
Cleared Mar 02, 2011
PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM
K110456 · KZE
Pharmajet, Inc.
General Hospital · 14d
Cleared Feb 25, 2011
VINYL EXAMINATION GLOVE POWDER FREE (CLEAR, NON-COLRED) /YELLOW/WHITE)
K103772 · LYZ
Advanced Medical Devices Factory
General Hospital · 60d
Cleared Feb 25, 2011
MULTIPLE NAME
K103337 · LZA
Ideal Quality Sdn., Bhd.
General Hospital · 102d
Cleared Feb 25, 2011
STERRAD CYCLESURE BIOLOGICAL INDICATOR
K103222 · FRC
Advanced Sterilization Products
General Hospital · 116d
Cleared Feb 25, 2011
NON-CONTACT INFRARED THERMOMETER
K102947 · FLL
K-Jump Health Co., Ltd.
General Hospital · 144d
Cleared Feb 25, 2011
STERRAAD 100NX EXPRESS CYCLE TEST PACK
K092755 · FRC
Advanced Sterilization Products
General Hospital · 534d
Cleared Feb 24, 2011
TROPHON
K103059 · OUJ
Nanosonics Limited
General Hospital · 132d
Cleared Feb 24, 2011
PATIENT SAFE LUER CAP
K101708 · FMF
Retractable Technologies, Inc.
General Hospital · 252d
Cleared Feb 24, 2011
SPECTRASHIELD 9500 SURGICAL MASK
K090414 · ONT
Nexera Medical, Inc.
General Hospital · 736d
Cleared Feb 23, 2011
V-GO INSULIN DELIVERY SYSTEM
K103825 · LZG
Valeritas, Inc.
General Hospital · 55d
Cleared Feb 23, 2011
ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO
K103264 · FEB
Olympus Medical Systems Corporation
General Hospital · 111d
Cleared Feb 23, 2011
FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK
K102971 · FYA
Microtek Medical, Inc.
General Hospital · 140d
Cleared Feb 23, 2011
INDISCAL DIGITAL MANOMETER
K102192 · FMF
Baylis Medical Co., Inc.
General Hospital · 203d
Cleared Feb 18, 2011
STERILIZATION MATS
K103226 · KCT
STERIS Corporation
General Hospital · 109d
Cleared Feb 18, 2011
PATIENT EXAMINATION GLOES
K102840 · LYY
Thai Hua Holding Co., Ltd.
General Hospital · 142d
Cleared Feb 18, 2011
VTS1000
K101838 · KZA
Vuetek Scientific, LLC
General Hospital · 232d