FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

5,280 results for "health"
2137–2160 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 23, 2011
INGENUITY TF PET/MR
K103483 · OUO
Philips Healthcare (Cleveland)
Radiology · 362d
Cleared Nov 23, 2011
ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I
K102644 · GKZ
Siemens Healthcare Diagnostics
Hematology · 435d
Cleared Nov 22, 2011
DIMENSION CLINICAL CHEMISTRY SYSTEM
K112999 · JJE
Siemens Healthcare Diagnostics
Chemistry · 46d
Cleared Nov 22, 2011
ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR
K112273 · DXN
Accumed Healthcare (Shanghai), Inc.
Cardiovascular · 106d
Cleared Nov 22, 2011
ACCUMED WRIST AUTOMATIC BLOOD PRESSURE MONITOR
K112270 · DXN
Accumed Healthcare (Shanghai), Inc.
Cardiovascular · 106d
Cleared Nov 22, 2011
DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL
K112220 · BZD
Devilbiss Healthcare, LLC
Anesthesiology · 112d
Cleared Nov 17, 2011
MOBCARDIO SYSTEM
K113234 · DPS
Mobhealth Incorporation
Cardiovascular · 15d
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