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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

5,198 results for "health"
2617–2640 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 21, 2007
CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0
K070941 · NBW
Taidoc Technology Corporation
Chemistry · 78d
Cleared Jun 21, 2007
DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200
K070491 · FLL
K-Jump Health Co., Ltd.
General Hospital · 121d
Cleared Jun 18, 2007
DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND L-CICU05A...
K071020 · MHX
Ge Healthcare
Cardiovascular · 69d
Cleared Jun 14, 2007
LUMILOC (TM) SAFETY INTRODUCER NEEDLE
K070449 · KNT
Specialized Health Products...
Gastroenterology & Urology · 119d
Cleared Jun 07, 2007
HEALTH CHECK KIOSK
K063008 · DXN
Xperex Corporation
Cardiovascular · 248d
Cleared May 25, 2007
INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES
K071222 · MEB
Baxter Healthcare Corp
General Hospital · 23d
Cleared May 24, 2007
TEXIUM SYRINGE
K071108 · FMF
Cardinal Health, Alaris Products
General Hospital · 35d
Cleared May 16, 2007
REPROCESSED LIGASURE VESSEL SEALER/DIVIDER
K062525 · GEI
Ascent Healthcare Solutions
General & Plastic Surgery · 261d
Cleared May 11, 2007
SKIPPI POWERED WHEELCHAIR FOR CHILDREN
K070318 · ITI
Otto Bock Healthcare LP
Physical Medicine · 98d
Cleared May 11, 2007
MODIFICATION TO FLOWSCREEN
K062011 · BTY
Viasys Healthcare GmbH
Anesthesiology · 298d
Cleared May 09, 2007
COLIN PRESS MATE, MODEL BP S510
K063690 · MHX
Omron Healthcare, Inc.
Cardiovascular · 148d
Cleared May 08, 2007
AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS
K071162 · MQB
Agfa Healthcare Corp.
Radiology · 12d
Not Cleared May 08, 2007
3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE
DEN060009 · NZJ
3M Company
General Hospital · 217d
Cleared May 07, 2007
TOP-RANK ADHESIVE ELECTRODE
K070612 · GXY
Top-Rank Health Care Equipment Co., Ltd.
Neurology · 63d
Cleared May 04, 2007
CORSCREEN
K070614 · DPS
Viasys Healthcare GmbH
Cardiovascular · 60d
Cleared May 03, 2007
AUTOVENT MODEL 4000
K070120 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 111d
Cleared May 02, 2007
COOL-TIP SWITCHING CONTROLLER, CTSW CONTROL
K070446 · GEI
Valleylab,A Division of Tyco...
General & Plastic Surgery · 76d
Cleared Apr 18, 2007
COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC1208
K070091 · KNW
Cardinal Health, Inc.
Gastroenterology & Urology · 98d
Cleared Apr 17, 2007
HEALTH MASK
K070467 · OBN
Polar Wrap, LLC
Anesthesiology · 60d
Cleared Apr 16, 2007
COLLEAGUE GUARDIAN CONFIGURATION TOOL
K070125 · FRN
Baxter Healthcare Corp
General Hospital · 90d
Cleared Apr 11, 2007
WILLSON ONE-FIT FLAT-FOLD HEALTHCARE PARTICULATE RESPIRATOR AND SURGICAL...
K070782 · MSH
Survivair Respirators, LLC
General Hospital · 21d
Cleared Mar 29, 2007
REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER
K063076 · OWQ
Ascent Healthcare Solutions
Cardiovascular · 174d
Cleared Mar 28, 2007
MODIFICATION TO HEALTH BUDDY APPLIANCE
K070543 · DRG
Health Hero Network, Inc.
Cardiovascular · 30d
Cleared Mar 23, 2007
PET VCAR
K063324 · JAK
Ge Healthcare
Radiology · 140d