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
4249–4272 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 14, 2012
POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM
K102189 · LZC
Latexx Manufacturing Sdn.Bhd.
General Hospital · 590d
Cleared Mar 12, 2012
SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER
K113429 · FOZ
Nipro Medical Corporation
General Hospital · 112d
Cleared Mar 09, 2012
KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE
K113423 · LZA
Kimberly-Clark Corp.
General Hospital · 109d
Cleared Mar 06, 2012
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K120358 · LYZ
Hongxin Plastic Products Co., Ltd.
General Hospital · 29d
Cleared Mar 06, 2012
DISPOSABLE VINYL EXAM GLOVE, POWDERED
K113790 · LYZ
Full Synergy Medical Products, Inc.
General Hospital · 74d
Cleared Mar 05, 2012
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, WHITE COLOR
K113750 · LYZ
Full Synergy Medical Products, Inc.
General Hospital · 75d
Cleared Mar 05, 2012
TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH...
K113422 · FMI
Terumo (Philippines) Corporation
General Hospital · 105d
Cleared Mar 05, 2012
SYMBIQ INFUSION AND ADMINSTRATION SET
K110901 · FRN
Hospira, Inc.
General Hospital · 340d
Cleared Mar 02, 2012
DISPOSABLE VINYL EXAM GLOVE, POWDER FREE
K113797 · LYZ
Full Synergy Medical Products, Inc.
General Hospital · 70d
Cleared Mar 02, 2012
E-CARE INFRARED EAR THERMOMETER
K113095 · FLL
E-Care Technology Corporation
General Hospital · 135d
Cleared Mar 01, 2012
FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER
K120304 · FOS
Footprint Medical, Inc.
General Hospital · 29d
Cleared Mar 01, 2012
CURAD COMPRESSION HOSIERY
K112769 · DWL
Medline Industries, Inc.
General Hospital · 160d
Cleared Mar 01, 2012
SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE
K111841 · FMF
Chengdu Xinjin Shifeng Med Appratus...
General Hospital · 246d
Cleared Feb 24, 2012
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM
K120314 · MRZ
Welldoc, Inc.
General Hospital · 23d
Cleared Feb 24, 2012
AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE)
K113587 · MEG
Shantou Wealy Medical Instrument Co.,Ltd
General Hospital · 81d
Cleared Feb 24, 2012
SITESCRUB IPA DEVICE
K112791 · LKB
C. R. Bard
General Hospital · 151d
Cleared Feb 24, 2012
SOL-M EXCHANGEABLE NEEDLES
K112777 · FMI
Sol-Milennium Medical, Inc.
General Hospital · 151d
Cleared Feb 21, 2012
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
K113520 · MED
STERIS Corporation
General Hospital · 84d
Cleared Feb 17, 2012
VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER
K113505 · FMI
Greiner Bio-One North America, Inc.
General Hospital · 81d
Cleared Feb 17, 2012
NANOBLUTM 500
K113206 · LBI
Draeger Medical Systems, Inc.
General Hospital · 108d
Cleared Feb 17, 2012
POWDERFREE POLYISOPRENE SURGICAL GLOVES
K112654 · KGO
Pt. Medisafe Technologies
General Hospital · 158d
Cleared Feb 17, 2012
VALEO VT-601 SERIES IR THERMOMETER
K111463 · FLL
Valeo Corp.
General Hospital · 267d
Cleared Feb 16, 2012
I-PORT ADVANCE INJECTION PORT
K120337 · FOZ
Unomedical A/S
General Hospital · 13d
Cleared Feb 15, 2012
OLYMPUS INSTRUMENT TRAY
K110748 · KCT
Olympus Winter & Ibe GmbH
General Hospital · 335d