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"
2449–2472 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 13, 2009
STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002
K081264 · FMQ
Children'S Health First, Inc.
General Hospital · 284d
Cleared Feb 02, 2009
IMMULITE 2000 FREE T4
K083373 · CEC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 80d
Cleared Jan 30, 2009
ALL-IN-ONE CONTAINER
K090096 · KPE
Baxter Healthcare Corporation
General Hospital · 15d
Cleared Jan 30, 2009
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E
K090023 · LIH
Well-Life Healthcare Limited
Neurology · 25d
Cleared Jan 29, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7941
K083319 · DXN
Andon Health Co, Ltd.
Cardiovascular · 80d
Cleared Jan 29, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5904
K083318 · DXN
Andon Health Co, Ltd.
Cardiovascular · 80d
Cleared Jan 29, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5902
K083317 · DXN
Andon Health Co, Ltd.
Cardiovascular · 80d
Cleared Jan 29, 2009
FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7902
K083248 · DXN
Andon Health Co, Ltd.
Cardiovascular · 87d
Cleared Jan 29, 2009
FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7906
K083247 · DXN
Andon Health Co, Ltd.
Cardiovascular · 87d
Cleared Jan 29, 2009
FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5961
K083246 · DXN
Andon Health Co, Ltd.
Cardiovascular · 87d
Cleared Jan 26, 2009
BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND...
K083175 · JPA
Siemens Healthcare Diagnostics
Hematology · 90d
Cleared Jan 26, 2009
BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND...
K083159 · JPA
Siemens Healthcare Diagnostics
Hematology · 91d
Cleared Jan 23, 2009
PASTURE, MODELS: F550, A520
K083176 · NZJ
Pasture Pharma Pte, Ltd.
General Hospital · 87d
Cleared Jan 16, 2009
FORA TELEHEALTH SYSTEM
K083046 · DRG
Taidoc Technology Corporation
Cardiovascular · 94d
Cleared Jan 16, 2009
HEALTH MANAGER, VERSION 1.1
K081499 · DRG
Biocomfort Diagnostics GmbH & Co. KG
Cardiovascular · 232d
Cleared Jan 14, 2009
ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE
K083149 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 82d
Cleared Jan 08, 2009
MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS
K081703 · NBW
Entra Health Systems, Ltd.
Chemistry · 205d
Cleared Jan 07, 2009
CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE
K081924 · DXN
Calhealth, Inc.
Cardiovascular · 184d
Cleared Dec 30, 2008
CARESTREAM PACS, MODEL CARESTREAM PACS VII
K083673 · LLZ
Carestream Health, Inc.
Radiology · 19d
Cleared Dec 30, 2008
NICOLET CORTICAL STIMULATOR
K072964 · GYC
Cardinal Health, Inc.
Neurology · 438d
Cleared Dec 19, 2008
DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS,...
K082503 · DFH
Siemens Healthcare Diagnostics
Immunology · 112d
Cleared Dec 10, 2008
DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE,...
K071474 · NTV
Siemens Healthcare Diagnostics
Chemistry · 561d
Cleared Dec 02, 2008
MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT
K082539 · BTY
Cardinal Health Germany 234 GmbH
Anesthesiology · 91d
Cleared Nov 28, 2008
GE ENTROPY SENSOR
K082540 · GXY
Ge Healthcare
Neurology · 87d