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"
2233–2256 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 20, 2010
GALAXY LITE
K102031 · IOR
Future Mobility Healthcare, Inc.
Physical Medicine · 93d
Cleared Oct 18, 2010
CARESCAPE MONITOR B650
K102239 · MHX
GE Healthcare Finland Oy
Cardiovascular · 70d
Cleared Oct 15, 2010
PROTEGRITY SMT LATEX SURGICALGLOVES
K101811 · KGO
Cardinal Health, Inc.
General Hospital · 108d
Cleared Oct 13, 2010
IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD)
K102325 · GDW
Covidien, LLC, Formerly Registered AS...
General & Plastic Surgery · 57d
Cleared Oct 08, 2010
FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM
K100011 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 277d
Cleared Oct 07, 2010
4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ
K101166 · LLZ
Ge Healthcare
Radiology · 164d
Cleared Oct 05, 2010
GE LOGIQ P6/P6 PRO
K101874 · IYN
Ge Healthcare
Radiology · 95d
Cleared Oct 04, 2010
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K102096 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 69d
Cleared Oct 04, 2010
TRUSIGNAL SPO2 FINGERTIP SENSOR
K101871 · DQA
GE Healthcare Finland Oy
Anesthesiology · 90d
Cleared Oct 01, 2010
GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
K102104 · IYN
Wipro GE Healthcare Private, Ltd.
Radiology · 66d
Cleared Sep 30, 2010
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K093107 · DHB
Siemens Healthcare Diagnostics
Immunology · 364d
Cleared Sep 29, 2010
C2000 POWERED WHEELCHAIR
K101524 · ITI
Otto Bock Healthcare LP
Physical Medicine · 119d
Cleared Sep 28, 2010
BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH
K101477 · LFD
Glaxosmithkline Consumer Healthcare...
Dental · 123d
Cleared Sep 20, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534
K102356 · DXN
Andon Health Co, Ltd.
Cardiovascular · 32d
Cleared Sep 17, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513
K102353 · DXN
Andon Health Co, Ltd.
Cardiovascular · 29d
Cleared Sep 15, 2010
MEPILEX BORDER AG DRESSING
K100029 · FRO
Molnlycke Health Care
General & Plastic Surgery · 252d
Cleared Sep 13, 2010
MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL...
K102173 · MSH
Moldex/Metric, Inc.
General Hospital · 42d
Cleared Sep 10, 2010
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES
K101425 · LRG
Siemens Healthcare Diagnostics
Microbiology · 113d
Cleared Aug 31, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-930
K101950 · DXN
Andon Health Co, Ltd.
Cardiovascular · 50d
Cleared Aug 31, 2010
GE LOGIQ P5 MODEL H44662LD
K101878 · IYN
Ge Healthcare
Radiology · 56d
Cleared Aug 27, 2010
DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE
K101889 · ITH
Pivotal Health Solutions
Physical Medicine · 51d
Cleared Aug 19, 2010
SYNERGY CT PICC
K101329 · LJS
Health Line International Corporation
General Hospital · 99d
Cleared Aug 05, 2010
MULTI-PURPOSE HEALTH DEVICE
K093322 · BWK
Upc Medical Supplies, Inc. Dba United...
Neurology · 286d
Cleared Aug 04, 2010
CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K
K101198 · DXN
Computerized Screening, Inc.
Cardiovascular · 97d