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"
2905–2928 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 01, 2004
POWERED WHEELCHAIR, MODEL B-500
K041208 · ITI
Otto Bock Healthcare LP
Physical Medicine · 144d
Cleared Sep 30, 2004
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS...
K042267 · MSH
Inovel, LLC
General Hospital · 38d
Cleared Sep 30, 2004
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY
K042226 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 44d
Cleared Sep 29, 2004
ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE
K042015 · CGA
Bayer Healthcare, Diagnostics Division
Chemistry · 64d
Cleared Sep 24, 2004
MODIFIED SPACEMAKER SYSTEM
K042412 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 17d
Cleared Sep 17, 2004
BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
K042251 · GKZ
Bayer Healthcare, LLC
Hematology · 28d
Cleared Sep 13, 2004
DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER...
K041694 · FLL
Hangzhou Hua'An Medical & Health...
General Hospital · 83d
Cleared Sep 13, 2004
INFRARED EAR THERMOMETER, ET-100 SERIES
K041692 · FLL
Hangzhou Hua'An Medical & Health...
General Hospital · 83d
Cleared Sep 10, 2004
HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A,...
K041867 · NLF
Hygia Health Services, Inc.
Anesthesiology · 63d
Cleared Sep 09, 2004
CRANIAL HELMET
K041215 · MVA
Otto Bock Healthcare LP
Neurology · 122d
Cleared Sep 08, 2004
MODIFICATION TO: LIFTLOC SAFTEY INFUSION SET
K042234 · FPA
Specialty Health Products, Inc.
General Hospital · 21d
Cleared Sep 01, 2004
SHINMED MODE SW-988 UNTRASONIC NEBULIZER
K031370 · CAF
Shining World Health Care Co., Ltd.
Anesthesiology · 490d
Cleared Aug 31, 2004
MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY
K042273 · DXN
Health Hero Network, Inc.
Cardiovascular · 8d
Cleared Aug 31, 2004
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR MODEL# HL888
K042265 · DXN
Health & Life Co., Ltd.
Cardiovascular · 8d
Cleared Aug 31, 2004
HC604 CPAP HUMIDIFIER
K041900 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 48d
Cleared Aug 27, 2004
RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE
K041997 · MUJ
Radionics, A Division of Tyco...
Radiology · 32d
Cleared Aug 27, 2004
OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS
K041563 · LFD
Glaxosmithkline Consumer Healthcare,...
Dental · 78d
Cleared Aug 27, 2004
ACCUSOL DIALYSIS SOLUTION
K041428 · KPO
Baxter Healthcare Corp
Gastroenterology & Urology · 91d
Cleared Aug 27, 2004
MYOHEALTH CLENCHING INHIBITOR
K040315 · MQC
Mci-Myohealth Systems
Dental · 200d
Cleared Aug 20, 2004
BODY CLOCK STIMPLUS AND STIMPLUS PRO
K041359 · GZJ
Body Clock Health Care, Ltd.
Neurology · 91d
Cleared Aug 20, 2004
POWDER-FREE NITRILE EXAMINATION GLOVES
K041276 · LZA
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 100d
Cleared Aug 12, 2004
SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300
K033027 · GEI
Shining World Health Care Co., Ltd.
General & Plastic Surgery · 321d
Cleared Jul 20, 2004
DOVER ROB-NEL CATHETER
K040897 · KOD
Tyco Healthcare
Gastroenterology & Urology · 105d
Cleared Jul 19, 2004
RTX3320PSTN WIRELESS TELEHEALTH GATEWAY
K041816 · DRG
Rtx Healthcare A/S
Cardiovascular · 13d