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"
2089–2112 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 16, 2011
SNORERX 9.0
K112205 · LRK
Consumer Health Products, Inc.
Dental · 107d
Cleared Nov 16, 2011
HEALTHTRACKER
K110770 · DXN
Wistron Corporation
Cardiovascular · 243d
Cleared Nov 15, 2011
REPROCESSED HAND ACTIVATE SEALER/DIVIDER
K111600 · NUJ
Ascent Healthcare Solutions
General & Plastic Surgery · 160d
Cleared Nov 10, 2011
CS 1200
K112321 · EIA
Carestream Health, Inc.
Dental · 90d
Cleared Nov 09, 2011
POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50...
K112988 · LYY
Northstar Healthcare Holdings Limited
General Hospital · 34d
Cleared Nov 09, 2011
SPIRO PD
K103575 · BZG
Pmd Healthcare
Anesthesiology · 338d
Cleared Nov 04, 2011
DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE
K112142 · NDW
Siemens Healthcare Diagnostics
Chemistry · 101d
Cleared Nov 04, 2011
INTERDRY SILVER
K110715 · FRL
Milliken Healthcare Products, LLC
General Hospital · 234d
Cleared Nov 02, 2011
SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)
K112962 · MHX
Spacelabs Medical, Inc.
Cardiovascular · 28d
Cleared Nov 01, 2011
BODY ANALYSIS SCALE
K112951 · MNW
Shenzhen Healthcare Electronic...
Gastroenterology & Urology · 28d
Cleared Oct 27, 2011
DX-D 600
K112670 · KPR
Agfa Healthcare N.V.
Radiology · 43d
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
CARESTREAM PACS
K110919 · LLZ
Carestream Health, Inc.
Radiology · 202d
Cleared Oct 20, 2011
SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04
K101286 · BZR
Linde Healthcare AB
Anesthesiology · 531d
Cleared Oct 18, 2011
CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION...
K112893 · FPA
Baxter Healthcare Corporation
General Hospital · 15d
Cleared Oct 14, 2011
ADVIA CENTAUR VITAMIN D TOTAL ASSAY
K110586 · MRG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 227d
Cleared Oct 12, 2011
MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM
K111200 · DQK
Ge Healthcare
Cardiovascular · 166d
Cleared Oct 11, 2011
HEALTH-E-CONNECT SYSTEM
K102063 · NBW
Alr Technologies
Chemistry · 445d
Cleared Oct 06, 2011
DRYVIEW CHROMA IMAGING SYSTEM
K111566 · LMC
Carestream Health, Inc.
Radiology · 122d
Cleared Oct 05, 2011
SPEACELABS MULTIGAS MODULE
K112173 · CBR
Spacelabs Healthcare
Anesthesiology · 69d
Cleared Sep 30, 2011
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE
K112738 · NBW
Andon Medical Co., Ltd.
Chemistry · 10d
Cleared Sep 30, 2011
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
K112320 · DXN
Health & Life Co., Ltd.
Cardiovascular · 50d
Cleared Sep 30, 2011
DISCOVERY MR750W 3.0T
K103327 · LNH
Ge Healthcare Japan Corporation
Radiology · 322d