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
4345–4368 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 20, 2011
DURA BLUE STERILIZATION WRAP
K112283 · FRG
Cardinal Health200, LLC
General Hospital · 72d
Cleared Oct 20, 2011
DURA BLUE STERILIZATION WRAP
K112211 · FRG
Cardinal Health200, LLC
General Hospital · 79d
Cleared Oct 20, 2011
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE...
K111772 · LZA
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 119d
Cleared Oct 20, 2011
KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK,...
K111402 · FXX
Kimberly-Clark
General Hospital · 154d
Cleared Oct 20, 2011
DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES...
K110979 · LZA
Advanced Medical Products Sdn Bhd
General Hospital · 196d
Cleared Oct 18, 2011
THERMOFLASH(TM) INFRARED THERMOMETER
K112929 · FLL
Visiomed Group SA
General Hospital · 15d
Cleared Oct 18, 2011
CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION...
K112893 · FPA
Baxter Healthcare Corporation
General Hospital · 15d
Cleared Oct 17, 2011
MICROGARD II
K111408 · CAH
Carefusion Germany 234 GmbH
General Hospital · 151d
Cleared Oct 14, 2011
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM
K112370 · MRZ
Welldoc, Inc.
General Hospital · 58d
Cleared Oct 14, 2011
MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES
K110250 · LYY
Total Gloves Sdn Bhd
General Hospital · 259d
Cleared Oct 13, 2011
INVISIPORT
K110407 · LJT
Stealth Therapeutics, Incorporated
General Hospital · 241d
Cleared Oct 06, 2011
CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS...
K111343 · FXX
Crosstex International, Inc.
General Hospital · 146d
Cleared Oct 04, 2011
SHAKER DIGITAL THERMOMETER
K112703 · FLL
Measure Technology Co. , Ltd.
General Hospital · 18d
Cleared Oct 04, 2011
DIGITAL CLINICAL THERMOMETER MODEL V901US
K112116 · FLL
Amperor-Electronic(Sz) Co., Ltd.
General Hospital · 71d
Cleared Oct 04, 2011
VENOTRAIN CURAFLOW
K111662 · DWL
Bauerfeind AG
General Hospital · 112d
Cleared Oct 03, 2011
CHIENMAX VIETNAM CO. LTD POWDER FREE BLUE NITRILE EXAMINATION GLOVE
K103675 · LZA
Chienmax Vietnam Co., Ltd.
General Hospital · 291d
Cleared Sep 30, 2011
BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
K111366 · FOZ
Becton, Dickinson and Company (BD)
General Hospital · 137d
Cleared Sep 29, 2011
TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE
K112136 · KKX
Kunshan Jiehong Nonwoven Product Co.,...
General Hospital · 65d
Cleared Sep 29, 2011
PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES
K111878 · KGO
Cardinal Health, Inc.
General Hospital · 90d
Cleared Sep 29, 2011
TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX...
K111351 · FPA
Us Infusion Dba Truecare Biomedix
General Hospital · 139d
Cleared Sep 29, 2011
MV INTRADERMIC NEEDLES
K110606 · FMI
M.V.S.R.L.
General Hospital · 210d
Cleared Sep 23, 2011
KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK
K103150 · OXZ
Kimberly-Clark
General Hospital · 332d
Cleared Sep 22, 2011
RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE
K112347 · FOZ
Vascular Pathways, Inc.
General Hospital · 38d
Cleared Sep 22, 2011
27 G X 1/2 K-PACK SURSHIELD NEEDLE
K111797 · FMI
Terumo Europe N.V.
General Hospital · 90d