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"
2305–2328 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 24, 2010
CLAYTON INTRA-AURAL DEVICE (CID)
K091880 · MQC
Ascentia Health Incorporated
Dental · 245d
Cleared Feb 19, 2010
INTOUCH DIABETES
K093789 · NBW
Symcare Personalized Health...
Chemistry · 72d
Cleared Feb 17, 2010
AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER
K100242 · FZP
Surgical Devices, A Division of Tyco...
General & Plastic Surgery · 21d
Cleared Feb 17, 2010
XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150,...
K093120 · KDI
Baxter Healthcare Corporation - Renal...
Gastroenterology & Urology · 138d
Cleared Feb 16, 2010
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL158BT
K093824 · DXN
Health & Life Co., Ltd.
Cardiovascular · 64d
Cleared Feb 12, 2010
B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644
K093631 · CDD
Siemens Healthcare Diagnostics
Chemistry · 80d
Cleared Feb 09, 2010
TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM
K093379 · KDI
Bl Healthcare, Inc.
Gastroenterology & Urology · 103d
Cleared Feb 05, 2010
OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407
K091757 · NUH
Well-Life Healthcare Limited
Neurology · 234d
Cleared Jan 29, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-557
K100014 · DXN
Andon Health Co, Ltd.
Cardiovascular · 25d
Cleared Jan 27, 2010
AIRVO SERIES HUMIDIFIERS
K092846 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 134d
Cleared Jan 26, 2010
MICROSCAN MICROSTREP PLUS, MODEL B1027-201
K091949 · LTT
Siemens Healthcare Diagnostics
Microbiology · 209d
Cleared Jan 22, 2010
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888V, FULL AUTOMATIC...
K093823 · DXN
Health & Life Co., Ltd.
Cardiovascular · 39d
Cleared Jan 22, 2010
LAPAROSCOPIC RETRACTORS
K092684 · GCJ
Cardinal Health, Inc.
General & Plastic Surgery · 143d
Cleared Jan 14, 2010
ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE...
K091867 · CDZ
Siemens Healthcare Diagnostics
Chemistry · 205d
Cleared Jan 13, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7035B, KD-7921,...
K092811 · DXN
Andon Health Co, Ltd.
Cardiovascular · 121d
Cleared Jan 07, 2010
DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES
K092447 · FLL
Hangzhou Hua'An Medical & Health...
General Hospital · 150d
Cleared Dec 29, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5910,KD-5911,...
K092588 · DXN
Andon Health Co, Ltd.
Cardiovascular · 127d
Cleared Dec 23, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-571, KD-7971
K093452 · DXN
Andon Health Co, Ltd.
Cardiovascular · 48d
Cleared Dec 23, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905,...
K092510 · DXN
Andon Health Co, Ltd.
Cardiovascular · 128d
Cleared Dec 18, 2009
SMART TENS, MODEL: D-BC05T
K091045 · GZJ
Body Clock Health Care, Ltd.
Neurology · 249d
Cleared Dec 17, 2009
HEALTHEPOD
K083174 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 416d
Cleared Dec 16, 2009
IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM
K091361 · LIP
Siemens Healthcare Diagnostics
Microbiology · 222d
Cleared Dec 04, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5963, KD-7963
K093528 · DXN
Andon Health Co, Ltd.
Cardiovascular · 18d
Cleared Dec 04, 2009
UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES
K092514 · DXN
Hangzhou Hua'An Medical & Health...
Cardiovascular · 109d