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
4273–4296 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 14, 2012
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR
K113722 · LYZ
Full Synergy Medical Products, Inc.
General Hospital · 57d
Cleared Feb 14, 2012
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR
K113710 · LYZ
Full Synergy Medical Products, Inc.
General Hospital · 57d
Cleared Feb 09, 2012
FLEXI-Q DV AND DVR AUTO-INJECTORS
K111467 · KZH
Elcam Medical Acal
General Hospital · 259d
Cleared Feb 08, 2012
YOMURA SAFETY I.V. CATHETER
K112542 · FOZ
Yomura Technologies, Inc.
General Hospital · 160d
Cleared Feb 07, 2012
SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS...
K112591 · FRG
Safe Secure Packaging Co., Ltd.
General Hospital · 153d
Cleared Feb 06, 2012
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K113100 · LZA
Maxter Glove Manufacturing Sdn Bhd
General Hospital · 110d
Cleared Feb 03, 2012
BRIGHT EMBRACE MODEL SBL60
K110550 · LBI
Physician Engineered Products, Inc.
General Hospital · 343d
Cleared Feb 02, 2012
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM
K112976 · LZA
Hartalega Snd. Bhd.
General Hospital · 119d
Cleared Feb 01, 2012
SPSMEDICAL SPORVIEW STEAM BI
K111515 · FRC
Spsmedical Supply Corp.
General Hospital · 245d
Cleared Jan 30, 2012
AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
K113555 · NGT
Am USA
General Hospital · 60d
Cleared Jan 30, 2012
ALDAHOL V HIGH LEVEL DISINFECTANT
K113015 · MED
Microchem Laboratories, Inc.
General Hospital · 111d
Cleared Jan 30, 2012
SMART READ EZTEST STEAM
K112018 · FRC
Mesa Laboratories, Inc.
General Hospital · 200d
Cleared Jan 30, 2012
BIOGEL (R) INDICATOR (R) UNDERGLOVE
K111413 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 255d
Cleared Jan 27, 2012
CATHETER CONNECTIONS' DUALCAP SOLO
K113842 · QBP
Catheter Connections, Inc.
General Hospital · 30d
Cleared Jan 27, 2012
MICROLIFE DUAL MODE THERMOMETER,MODEL IFR1MJ1
K113141 · FLL
Microlife Intellectual Property GmbH
General Hospital · 95d
Cleared Jan 26, 2012
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH...
K111134 · LZA
Siem Aempemed Corp., Ltd.
General Hospital · 279d
Cleared Jan 26, 2012
CLICKFINE AUTOPROTECT PEN NEEDLE
K110312 · FMI
Ypsomed AG
General Hospital · 358d
Cleared Jan 24, 2012
STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS
K112904 · FRG
Case Medical, Inc.
General Hospital · 112d
Cleared Jan 20, 2012
NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS
K113302 · FRC
North American Science Assoc., Inc.
General Hospital · 73d
Cleared Jan 20, 2012
SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM
K112936 · MEG
Rexam Consummer Plastics Inc.D/B/A...
General Hospital · 109d
Cleared Jan 20, 2012
DURABLUE STERILIZATION (AMSCO V-PRO) WRAP
K112918 · FRG
Cardinal Health200, LLC
General Hospital · 109d
Cleared Jan 19, 2012
KIMGUARD SMART-FOLD* STERILIZATION WRAP
K112300 · FRG
Kimberly-Clark Corp.
General Hospital · 162d
Cleared Jan 18, 2012
POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM
K112612 · LYY
Top Calibre Sdn Bhd
General Hospital · 133d
Cleared Jan 13, 2012
THERMO PAL INFRARED EAR THERMOMETER
K112189 · FLL
Digio2 International Co., Ltd.
General Hospital · 168d