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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
116137–116160 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 1992
DURACON ALL PLASTIC TIBIAL COMPONENT
K922048 · JWH
Howmedica Corp.
Orthopedic · 130d
Cleared Sep 08, 1992
OMEGA PLUS COMPRESS HIP SCREW SYSTEM, MODIFICATION
K922295 · KTT
Howmedica Corp.
Orthopedic · 116d
Cleared Sep 04, 1992
ACUSON S228 TRANSDUCER FOR TRANSCRANIAL COLOR DOPP
K902515 · ITX
Acuson Corp.
Radiology · 822d
Cleared Sep 04, 1992
SINGH SPEECH SYSTEM (SERIES 'SSS')
K912486 · EWL
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 458d
Cleared Sep 04, 1992
4240 DYNAMIC BP/HEART RATE MONITOR
K914260 · DXN
Suntech Medical Instruments, Inc.
Cardiovascular · 347d
Cleared Sep 04, 1992
OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE
K920439 · EOB
Omega Universal Technologies, Ltd.
Ear, Nose, Throat · 214d
Cleared Sep 04, 1992
TRI-MED QUICK-STEP GASTRIC LAVAGE KIT
K920527 · KDH
Tri-Med Specialties, Inc.
Gastroenterology & Urology · 213d
Cleared Sep 04, 1992
TRI-MED GASTRIC LAVAGE SYSTEM
K920619 · KDH
Tri-Med Specialties, Inc.
Gastroenterology & Urology · 206d
Cleared Sep 04, 1992
MODEL ELI 200 ELECTROCARDIOGRAPH
K920626 · LOS
Mortara Instrument, Inc.
Cardiovascular · 219d
Cleared Sep 04, 1992
MODEL ELI 100 ELECTROCARDIOGRAPH
K920627 · LOS
Mortara Instrument, Inc.
Cardiovascular · 219d
Cleared Sep 04, 1992
LABORIE URODYNAMICS PROCESSOR
K920777 · FAP
R. Laborie Surgical , Ltd.
Gastroenterology & Urology · 197d
Cleared Sep 04, 1992
NEW FREEDOM ULTRA THIN PADS
K920830 · HHD
Kimberly-Clark Corp.
Obstetrics & Gynecology · 193d
Cleared Sep 04, 1992
GUIDEWIRE
K921200 · KNY
Lake Region Mfg., Inc.
Gastroenterology & Urology · 176d
Cleared Sep 04, 1992
IRRIGATION TUBING SET
K921415 · KOD
Psi Medical Products, Inc.
Gastroenterology & Urology · 164d
Cleared Sep 04, 1992
DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST
K922364 · IXR
Toshiba America Medical Systems, In.C
Radiology · 108d
Cleared Sep 04, 1992
SUPER GLOVES(R) HYPOALLERGENIC
K922495 · LYY
Taiping Super Holdings Sdn Bhd
General Hospital · 100d
Cleared Sep 04, 1992
MAGNETIZATION TRANSFER CONTRAST
K922677 · LNH
Resonex, Inc.
Radiology · 92d
Cleared Sep 04, 1992
STARKEY LABORATORIES OTOSCOPE
K922752 · ERA
Starkey Laboratories, Inc.
Ear, Nose, Throat · 88d
Cleared Sep 04, 1992
OXYGEN SWIVEL ADAPTER (PLASTIC)
K924225 · BZA
Linjorel Products, Inc.
Anesthesiology · 14d
Cleared Sep 03, 1992
VITAL INFUSION PUMP
K914122 · FRN
Vital Resources Corp.
General Hospital · 356d
Cleared Sep 03, 1992
MONOPOLAR ELECTRODE
K915296 · GEI
Lifeguard Medical Products, Inc.
General & Plastic Surgery · 293d
Cleared Sep 03, 1992
AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR
K915737 · DTN
Electromedics, Inc.
Cardiovascular · 258d
Cleared Sep 03, 1992
DUAL LEAD (ECG1 & ECG2) ARRHYTHMIA ANALYSIS
K920743 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 202d
Cleared Sep 03, 1992
MEDI-STIM
K921491 · LIH
Mid-Canada Medical
Neurology · 157d