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"
1921–1944 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 08, 2013
AMBIO REMOTE HEALTH MONITORING SYSTEM
K130676 · DRG
Arrayent Health, LLC D/B/A Ambio Health
Cardiovascular · 118d
Cleared Jul 05, 2013
TIBURON SURGICAL DRAPE
K130404 · KKX
Cardinal Health200, LLC
General Hospital · 136d
Cleared Jun 25, 2013
EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI)
K121628 · DXH
Epi Mobile Health Solutions (S) Pte,...
Cardiovascular · 386d
Cleared Jun 23, 2013
PROTEUS PATCH INCLUDING INGESTIBLE SENSOR
K131524 · OZW
Proteus Digital Health, Inc.
Gastroenterology & Urology · 26d
Cleared Jun 19, 2013
VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10
K131267 · IYN
Ge Healthcare
Radiology · 47d
Cleared Jun 19, 2013
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
K130564 · DXN
Health & Life Co., Ltd.
Cardiovascular · 107d
Cleared Jun 18, 2013
DURABLUE STERILIZATION WRAP
K130927 · FRG
Cardinal Health200, LLC
General Hospital · 76d
Cleared Jun 18, 2013
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
K130563 · DXN
Health & Life Co., Ltd.
Cardiovascular · 106d
Cleared Jun 18, 2013
VIVO 50
K123144 · NOU
Ge Healthcare, Breas Medical AB
Anesthesiology · 256d
Cleared Jun 14, 2013
TORC BODY
K131291 · NGX
Johari Digital Healthcare , Ltd.
Physical Medicine · 39d
Cleared Jun 14, 2013
ENFLOW IV FLUID WARMER INSULATED STRAP
K130867 · LGZ
Vital Signs, Inc., A GE Healthcare...
General Hospital · 78d
Cleared Jun 11, 2013
DR LONG LENGTH IMAGING SOFTWARE
K130567 · MQB
Carestream Health, Inc.
Radiology · 99d
Cleared Jun 07, 2013
CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR
K130464 · MQB
Carestream Health, Inc.
Radiology · 105d
Cleared Jun 07, 2013
IMR SOFTWARE APPLICATION
K123576 · JAK
Philips Healthcare (Cleveland)
Radiology · 199d
Cleared Jun 05, 2013
F&P SIMPLUS FULL FACE MASK
K130328 · BZD
Fisher & Paykel Healthcare Limited
Anesthesiology · 114d
Cleared May 29, 2013
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
K131121 · DXN
Health & Life Co., Ltd.
Cardiovascular · 37d
Cleared May 17, 2013
OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME
K123603 · OXO
Ge Healthcare Surgery GE Oec Medical...
Radiology · 177d
Cleared May 16, 2013
4D VIEW
K131118 · LLZ
Ge Healthcare
Radiology · 24d
Cleared May 14, 2013
SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100
K123985 · JAD
Sensus Healthcare
Radiology · 139d
Cleared May 13, 2013
QLAB QUANTIFICATION SOFTWARE HEART MODEL
K130159 · LLZ
Philips Health Care
Radiology · 110d
Cleared May 07, 2013
PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY)
K131009 · OZW
Proteus Digital Health, Inc.
Gastroenterology & Urology · 26d
Cleared Apr 22, 2013
STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK
K123539 · DXN
Stayhealthy, Inc.
Cardiovascular · 157d
Cleared Apr 22, 2013
XHIBIT CENTRAL STATION, MODEL 96102
K122146 · MHX
Spacelabs Healthcare
Cardiovascular · 277d
Cleared Apr 19, 2013
MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM
K122539 · CHL
Siemens Healthcare Diagnostics
Chemistry · 241d