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"
2281–2304 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 10, 2010
BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM
K101078 · DRG
Bl Healthcare, Inc.
Cardiovascular · 21d
Cleared May 10, 2010
ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF...
K100289 · KHS
Siemens Healthcare Diagnostics
Chemistry · 97d
Cleared May 10, 2010
VLOC9ABSORBABLE WOUND CLOSURE DEVICE
K100257 · GAM
Surgical Devices, A Division of Tyco...
General & Plastic Surgery · 102d
Cleared May 10, 2010
ACTIPROTECT UF N95 RESPIRATOR
K093161 · ONT
Glaxosmithkline Consumer Healthcare
General Hospital · 216d
Cleared May 05, 2010
DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A
K100778 · JIX
Siemens Healthcare Diagnostics
Chemistry · 47d
Cleared May 04, 2010
ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY...
K100523 · NMD
Hygia Health Services, Inc.
Cardiovascular · 69d
Cleared Apr 27, 2010
F&P ICON SERIES CPAP
K094040 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 118d
Cleared Apr 26, 2010
VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP
K100548 · GCJ
Covidien Lp, Formerly Registered AS...
General & Plastic Surgery · 59d
Cleared Apr 15, 2010
LASERTOUCHONE (OTC)
K100116 · NUH
Laser Health Technologies, LLC
Neurology · 90d
Cleared Apr 09, 2010
PEAK EXPIRATORY FLOW METER, KN-9710
K092335 · BZH
K-Jump Health Co., Ltd.
Anesthesiology · 248d
Cleared Apr 07, 2010
DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435
K093441 · KXT
Siemens Healthcare Diagnostics
Chemistry · 153d
Cleared Apr 02, 2010
HELIOX LOW FLOW SENTRY BLENDER
K092484 · BZR
Cardinal Health 207, Inc.
Anesthesiology · 232d
Cleared Apr 02, 2010
ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01
K091933 · BWK
Inno-Health Technology, Inc.
Neurology · 276d
Cleared Apr 02, 2010
MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY
K091716 · CAW
Merits Health Products Co., Ltd.
Anesthesiology · 296d
Cleared Mar 25, 2010
FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT
K093831 · DXN
Health & Life Co., Ltd.
Cardiovascular · 101d
Cleared Mar 24, 2010
EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT
K091890 · MED
Healthpoint, Ltd.
General Hospital · 274d
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