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"
2497–2520 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 27, 2009
DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350
K083462 · JIT
Siemens Healthcare Diagnostics
Chemistry · 95d
Cleared Feb 27, 2009
SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS:...
K083395 · DXN
Andon Health Co, Ltd.
Cardiovascular · 102d
Cleared Feb 26, 2009
ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL
K082638 · KLI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 169d
Cleared Feb 26, 2009
COPA AMD
K082296 · FRO
Covidien Lp, Formerly Registered AS...
General & Plastic Surgery · 198d
Cleared Feb 20, 2009
XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210
K083778 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 63d
Cleared Feb 20, 2009
DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360
K083579 · JIX
Siemens Healthcare Diagnostics
Chemistry · 78d
Cleared Feb 18, 2009
ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS
K083735 · JOM
Medtechs, LLC
Cardiovascular · 64d
Cleared Feb 18, 2009
MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32...
K083262 · LTT
Siemens Healthcare Diagnostics
Microbiology · 105d
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