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"
1777–1800 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 19, 2014
IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL
K141772 · JJX
Siemens Healthcare Diagnostics, Inc.
Microbiology · 49d
Cleared Aug 18, 2014
SOLUTION SET/EXTENSION SET
K142011 · FPA
Baxter Healthcare Corporation
General Hospital · 25d
Cleared Aug 18, 2014
3M STERI-DRAPE FABRIC SURGICAL DRAPES
K140330 · KKX
3M Healthcare
General Hospital · 189d
Cleared Aug 07, 2014
KIMGUARD ONE-STEP STERILIZATION WRAP
K141612 · FRG
Kimberly-Clark Health Care
General Hospital · 52d
Cleared Aug 04, 2014
LOGIQ V5/LOGIQ V3
K141768 · IYN
Ge Healthcare
Radiology · 34d
Cleared Aug 04, 2014
DEVILBISS SMARTLINK II SYSTEM
K140880 · BZD
Devilbiss Healthcare, LLC
Anesthesiology · 119d
Cleared Jul 28, 2014
KIMGUARD ONE-STEP STERILIZATION WRAP
K141071 · FRG
Kimberly-Clark Health Care
General Hospital · 94d
Cleared Jul 25, 2014
VOLUSON P6, VOLUSON P8
K141675 · IYN
Ge Healthcare
Radiology · 30d
Cleared Jul 25, 2014
3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE
K140250 · KKX
3M Healthcare
General Hospital · 175d
Cleared Jul 25, 2014
BELTER BLOOD PRESSURE METER
K134029 · DXN
Shenzhen Belter Health Measurement...
Cardiovascular · 206d
Cleared Jul 24, 2014
ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY
K133156 · MRG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 280d
Cleared Jul 18, 2014
VOLUSON S6, VOLUSON S8
K141639 · IYN
Ge Healthcare
Radiology · 29d
Cleared Jul 15, 2014
PULSTAR LOGIX PUMP
K141609 · JOW
Albahealth, LLC
Cardiovascular · 29d
Cleared Jul 11, 2014
THE STORK OTC
K140186 · OBB
Rinovum Women'S Health, Inc.
Obstetrics & Gynecology · 168d
Cleared Jul 09, 2014
IMMULITE 2000
K141444 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 37d
Cleared Jul 07, 2014
GRAB 'N GO PLUS, GRAB 'N GO DIGITAL
K132778 · ECX
Praxair Healthcare Services
Anesthesiology · 305d
Cleared Jul 02, 2014
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K140121 · DXN
Andon Health Co, Ltd.
Cardiovascular · 167d
Cleared Jun 30, 2014
POWDER FREE BLUDE NITRILE PATIENT EXAMINATION GLOVE, NON-STERILE
K132354 · LZA
Advanced Health Products, Lot 60 & 61
General Hospital · 336d
Cleared Jun 24, 2014
IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL
K133816 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 190d
Cleared Jun 23, 2014
CONTOUR NEXT EZ BLOOD GLUCOSE METER
K130265 · NBW
Bayer Healthcare, LLC
Chemistry · 504d
Cleared Jun 20, 2014
SECURE-GARD SURGICAL AND PROCEDURE FACE MASK
K140155 · FXX
Cardinal Health200, LLC
General Hospital · 149d
Cleared Jun 19, 2014
DISPOSABLE PRESSURE MANOMETER
K140370 · CAP
Besmed Health Business Corp
Anesthesiology · 125d
Cleared Jun 12, 2014
DURADIAGNOST
K141381 · KPR
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 16d
Cleared Jun 09, 2014
VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES
K140930 · FSY
Convida Healthcare & Systems Corporation
General & Plastic Surgery · 59d