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"
1753–1776 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 29, 2014
ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur...
K142864 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 28d
Cleared Oct 29, 2014
IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free...
K142811 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 30d
Cleared Oct 22, 2014
Ultra Silver Dressings
K141603 · FRO
Milliken Healthcare Products, LLC
General & Plastic Surgery · 128d
Cleared Oct 16, 2014
DX-D IMAGING PACKAGE
K142184 · MQB
Agfa Healthcare N.V.
Radiology · 69d
Cleared Oct 10, 2014
Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System
K142323 · IYN
Ge Medical Systems Israel , Ltd.
Radiology · 51d
Cleared Oct 10, 2014
LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM
K142160 · IYN
Ge Healthcare
Radiology · 65d
Cleared Oct 10, 2014
OSTOM-I ALERT
K140938 · EXB
11 Health and Technologies, LLC
Gastroenterology & Urology · 182d
Cleared Oct 02, 2014
SAFE'N'SOUND STAKED PASSIVE DELIVERY SYSTEM - CONE VERSION
K141664 · MEG
Rexam Healthcare
General Hospital · 101d
Cleared Sep 30, 2014
CLAVEGUARD FREEDOM SURGICAL LIGHT
K142076 · FSY
Dickson & Dickson Healthcare (Us), Inc.
General & Plastic Surgery · 61d
Cleared Sep 30, 2014
COMP A-I-R
K141140 · CAF
Omron Healthcare, Inc.
Anesthesiology · 151d
Cleared Sep 26, 2014
SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE
K141113 · DXN
Spacelabs Healthcare, Ltd.
Cardiovascular · 149d
Cleared Sep 24, 2014
REACH ACCESS TELEMEDICINE DOSE CALCULATOR
K142123 · NDC
Reach Health, Inc.
General Hospital · 51d
Cleared Sep 12, 2014
DX-D IMAGING PACKAGE
K141602 · MQB
Agfa Healthcare N.V.
Radiology · 88d
Cleared Sep 12, 2014
WHISPERJECT AUTOINJECTOR
K141384 · KZH
Scandinavian Health Limited
General Hospital · 108d
Cleared Sep 10, 2014
ITRAC CERVICAL TRACTION SYSTEM
K131983 · ITH
Pivotal Health Solutions
Physical Medicine · 439d
Cleared Sep 09, 2014
SPACELABS HEALTHCARE TELEMETRY RECEIVER
K141156 · MHX
Spacelabs Healthcare
Cardiovascular · 127d
Cleared Sep 08, 2014
IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM
K133584 · CGA
Eoshealth, Inc.
Chemistry · 291d
Cleared Sep 04, 2014
BIOGEL PL MICRO SURGICAL GLOVE
K141719 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 71d
Cleared Sep 04, 2014
COMPAT ENTERAL DELIVERY PUMP SETS
K140947 · PIF
Nestle Healthcare Nutrition, Inc.
Gastroenterology & Urology · 143d
Cleared Sep 03, 2014
VOLUMETRIC INCENTIVE SPIROMETER
K141355 · BWF
Besmed Health Business Corporation
Anesthesiology · 103d
Cleared Aug 27, 2014
MONICA NOVII WIRELESS PATCH SYSTEM
K140862 · OSP
Monica Healthcare, Ltd.
Obstetrics & Gynecology · 146d
Cleared Aug 26, 2014
BASAL DIGITAL THERMOMETER
K141505 · FLL
K-Jump Health Co., Ltd.
General Hospital · 81d
Cleared Aug 21, 2014
BELTER INFRA-RED EAR THERMOMETER
K140681 · FLL
Shenzhen Belter Health Measurement...
General Hospital · 156d
Cleared Aug 20, 2014
NEXUS MIDLINE CT CATHETER
K140270 · FOZ
Health Line International Corporation
General Hospital · 198d