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"
2353–2376 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 22, 2010
ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770
K093732 · JIX
Siemens Healthcare Diagnostics
Chemistry · 108d
Cleared Mar 19, 2010
REPROCESSED TROCARS, MODEL B5LT AND CB5LT
K100080 · NLM
Ascent Healthcare Solutions
Gastroenterology & Urology · 66d
Cleared Mar 12, 2010
DIDGET WORLD REPORTS
K093930 · NBW
Bayer Healthcare, LLC
Chemistry · 80d
Cleared Mar 12, 2010
TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP...
K093881 · DQA
GE Healthcare Finland Oy
Anesthesiology · 84d
Cleared Mar 10, 2010
PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL...
K093124 · BZD
Cardinal Health 207, Inc.
Anesthesiology · 159d
Cleared Mar 05, 2010
EXL ANEM CAL, MODEL RC640
K093645 · JIX
Siemens Healthcare Diagnostics
Chemistry · 100d
Cleared Mar 04, 2010
REPROCESSED ULTRASONIC COAGULATING SHEARS
K093702 · NLQ
Ascent Healthcare Solutions
General & Plastic Surgery · 93d
Cleared Mar 04, 2010
MICRO-TOUCH NITRILE
K093523 · LZA
Ansell Healthcare Products, LLC
General Hospital · 111d
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