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"
1945–1968 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 20, 2012
HEALTHVIEW ECG MANAGER
K123466 · DQK
Lumedx
Cardiovascular · 41d
Cleared Dec 20, 2012
ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR
K123046 · DFC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 83d
Cleared Dec 18, 2012
LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM
K123564 · IYN
Ge Healthcare
Radiology · 28d
Cleared Dec 14, 2012
PERCUNAV
K121498 · JAK
Philips Health Care
Radiology · 207d
Cleared Dec 06, 2012
ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS
K122432 · BZE
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 118d
Cleared Nov 30, 2012
DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA...
K121994 · CDD
Siemens Healthcare Diagnostics, Inc.
Chemistry · 147d
Cleared Nov 28, 2012
ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER
K121775 · LGZ
Vital Signs, Inc., A GE Healthcare...
General Hospital · 163d
Cleared Nov 20, 2012
REMOTE PRESENCE SYSTEM, MODEL RP-VITA
K123229 · DRG
Intouch Health, Inc.
Cardiovascular · 36d
Cleared Nov 20, 2012
HEALTHMATEFOREVER
K121757 · NUH
Healthmate International, LLC
Neurology · 158d
Cleared Nov 19, 2012
NON-CONTACT THERMOMETER
K120711 · FLL
K-Jump Health Co., Ltd.
General Hospital · 256d
Cleared Nov 16, 2012
CENTRICITY PACS-IW WITH UNIVERSAL VIEWER
K123174 · LLZ
Ge Healthcare
Radiology · 37d
Cleared Nov 16, 2012
TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING...
K123026 · LYY
Northstar Healthcare Holdings
General Hospital · 49d
Cleared Nov 16, 2012
PEDIATRIC POSITIONER PAD SET
K122174 · KXH
Ge Healthcare Coils (Usa Instruments,...
Radiology · 116d
Cleared Nov 07, 2012
DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER)
K122912 · FLL
Hangzhou Hua'An Medical & Health...
General Hospital · 47d
Cleared Nov 06, 2012
BLUE POWDERED NITRILE EXAMINATION GLOVE
K122998 · LZA
Northstar Healthcare Holdings
General Hospital · 40d
Cleared Nov 02, 2012
FLIGHTPLAN FOR LIVER
K121200 · LLZ
Ge Healthcare
Radiology · 197d
Cleared Oct 23, 2012
CARESTREAM VUE PACS
K122523 · LLZ
Carestream Health, Inc.
Radiology · 64d
Cleared Oct 15, 2012
FINGERTIP PULSE OXIMETER
K121697 · DQA
Andon Health Co, Ltd.
Anesthesiology · 130d
Cleared Oct 12, 2012
RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS
K122398 · JIX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 66d
Cleared Oct 05, 2012
C1-6-D ULTRASOUND TRANSDUCER
K122921 · ITX
Ge Healthcare
Radiology · 11d
Cleared Oct 03, 2012
ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR
K122599 · DDR
Siemens Healthcare Diagnostics, Inc.
Chemistry · 37d
Cleared Oct 03, 2012
LOGIQ S7 EXPERT, LOGIQ S7 PRO
K122114 · IYN
Ge Healthcare
Radiology · 78d
Cleared Oct 03, 2012
AIDA VI.8 DIAGNOSTIC ULTRASOUND GM-72P00A, L13-5V1 TRANSDUCER
K122009 · IYN
Panasonic Healthcare Co., Ltd.
Radiology · 86d
Cleared Oct 02, 2012
ESON NASAL MASK
K121597 · BZD
Fisher & Paykel Healthcare Limited
Anesthesiology · 124d