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"
1825–1848 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 08, 2013
K-Y BRAND LIQUIBEADS
K122061 · NUC
Johnson & Johnson Healthcare Products
Obstetrics & Gynecology · 483d
Cleared Nov 06, 2013
BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET
K132048 · DWJ
Molnlycke Health Care Us, LLC
Cardiovascular · 127d
Cleared Nov 05, 2013
VIDA LED SURGICAL LIGHTING SYSTEM
K132307 · FSY
Convida Healthcare & Systems Corporation
General & Plastic Surgery · 104d
Cleared Oct 30, 2013
IMMULITE 2000
K133122 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 30d
Cleared Oct 25, 2013
IMMULITE 2000
K133124 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 25d
Cleared Oct 24, 2013
AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER
K131895 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 121d
Cleared Oct 23, 2013
OPTUM TELEHEALTH APPLICATION
K130971 · DRG
Optumhealth Care Solutions, Inc.
Cardiovascular · 198d
Cleared Oct 22, 2013
IMMULITE 2000
K133128 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 22d
Cleared Oct 16, 2013
ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP...
K132664 · CJW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 50d
Cleared Oct 10, 2013
NXSTAGE CONNECTED HEALTH SYSTEM
K131739 · FKP
Nxstage Medical, Inc.
Gastroenterology & Urology · 119d
Cleared Oct 10, 2013
IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL
K131662 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 125d
Cleared Oct 08, 2013
NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND...
K132734 · FPA
Baxter Healthcare Corp
General Hospital · 35d
Cleared Oct 07, 2013
HEM-6221
K131749 · DXN
Omron Healthcare, Inc.
Cardiovascular · 115d
Cleared Oct 03, 2013
MOTEX POWDER-FREE NITRILE SURGICAL GLOVES
K122557 · KGO
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 407d
Cleared Sep 27, 2013
TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR
K132696 · DQA
GE Healthcare Finland Oy
Anesthesiology · 29d
Cleared Sep 26, 2013
CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR
K122370 · NBW
Bayer Healthcare
Chemistry · 416d
Cleared Sep 24, 2013
VOLUSON I/E
K131937 · IYN
Ge Healthcare
Radiology · 89d
Cleared Sep 24, 2013
BRILLIANCE ICT
K131773 · JAK
Philips Healthcare (Cleveland)
Radiology · 99d
Cleared Sep 24, 2013
SHENGGUANG MANUAL WHEELCHAIR
K131529 · IOR
Pingdingshan Shenxing Healthcare...
Physical Medicine · 119d
Cleared Sep 17, 2013
CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT
K131977 · LLZ
Ge Healthcare
Radiology · 81d
Cleared Sep 13, 2013
ADVIA CENTAUR FT4, ADVIA CENTAUR T4
K132249 · CEC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 56d
Cleared Sep 13, 2013
LOBSTER AUTO-INJECTOR
K124026 · KZH
Scandinavian Health Limited
General Hospital · 259d
Cleared Sep 11, 2013
IHEALTH FINGERTIP PULSE OXIMETER
K131111 · DQA
Andon Health Co, Ltd.
Anesthesiology · 145d
Cleared Sep 06, 2013
FREEMIE BREAST COLLECTION SYSTEM
K130349 · HGX
Dao Health
Obstetrics & Gynecology · 206d