FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
123169–123192 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 1990
MRT35-SP
K905442 · LNH
Toshiba America Mri, Inc.
Radiology · 87d
Cleared Dec 21, 1990
PATIENT EXAM GLOVES(MFG: LIAONING MACHINERY)
K905585 · LYY
Pioneer Trading Co.
General Hospital · 8d
Cleared Dec 21, 1990
ELLIPSE 2.3
K905621 · IOR
Everest & Jennings, Inc.
Physical Medicine · 7d
Cleared Dec 20, 1990
THE OMNIFIT EPF HIP JOINT FEMORAL STEM
K896047 · MEH
Osteonics Corp.
Orthopedic · 428d
Cleared Dec 20, 1990
BODYHEAT
K902650 · DWJ
Medadvances, Inc.
Cardiovascular · 188d
Cleared Dec 20, 1990
KETOREX SANWA STANDARDS
K903365 · JIN
Ihara Medics U.S., Inc.
Chemistry · 147d
Cleared Dec 20, 1990
MAGNUM-20 (TM) INFLATION DEVICE
K903621 · MAV
Vascumed Systems
Cardiovascular · 134d
Cleared Dec 20, 1990
MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT
K903993 · DKZ
Immunotech Corp.
Chemistry · 113d
Cleared Dec 20, 1990
CARDIOMATIC MODEL MSC-2001
K904353 · DRT
Medical Systems Corp.
Cardiovascular · 87d
Cleared Dec 20, 1990
ANEROID BLOOD PRESSURE GAUGE
K904376 · FCY
Biomedical Dynamics, Inc.
Gastroenterology & Urology · 86d
Cleared Dec 20, 1990
ACUFIT TOTAL HIP
K904383 · KWY
Acu Med, Inc.
Orthopedic · 85d
Cleared Dec 20, 1990
FLEXIBLE ARTHROSCOPE
K904465 · HRX
Intramed Laboratories, Inc.
Orthopedic · 80d
Cleared Dec 20, 1990
VACUUM BAKE CYCLE
K904892 · DXY
Medtronic Vascular
Cardiovascular · 51d
Cleared Dec 20, 1990
PEDIATRIC AND INFANT CATH KITS
K905016 · FFH
Davol, Inc.
Gastroenterology & Urology · 43d
Cleared Dec 20, 1990
RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV
K905084 · CGS
Reagents Applications, Inc.
Chemistry · 36d
Cleared Dec 20, 1990
RAICHEM GGT REAGENT
K905085 · JQB
Reagents Applications, Inc.
Chemistry · 36d
Cleared Dec 20, 1990
NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFF
K905101 · DXQ
Hewlett-Packard Co.
Cardiovascular · 37d
Cleared Dec 20, 1990
LIFEPAK 9 DEFIBRILLATOR & CARDIAC MONITOR/MODIFIED
K905510 · LDD
Physio-Control Corp.
Cardiovascular · 13d
Cleared Dec 19, 1990
PERRY SV-1 HYPERBARIC VENTILATOR
K895513 · CBK
Perry Baromedical Services
Anesthesiology · 463d
Cleared Dec 19, 1990
GUARDIAN & JANITEX CONDOM/PROPHYLACTIC
K896098 · HIS
Allied Rubber Industries Sdn. Bhd.
Obstetrics & Gynecology · 425d
Cleared Dec 19, 1990
ANESTHETIC GAS CALIBRATION MIXTURE
K902754 · BXK
Liquid Air Corp.
Anesthesiology · 180d
Cleared Dec 19, 1990
MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICE
K902822 · GZJ
Medical Design & Manufacturing Corp.
Neurology · 175d
Cleared Dec 19, 1990
G.E. MST 625/625II/MST 1050/1050II THREE PHASE GEN
K902985 · IZO
Electromek Diagnostic Systems, Inc.
Radiology · 176d
Cleared Dec 19, 1990
G.E. MSI 850/850II/1250 THREE PHASE GENERATORS
K902988 · IZO
Electromek Diagnostic Systems, Inc.
Radiology · 176d