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
125641–125664 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 1990
EXPANDACEL NASAL TAMPONS
K900171 · EMX
Surgitrend, Ltd.
Ear, Nose, Throat · 153d
Cleared Jun 14, 1990
JAHN VENTILATION TUBE
K900267 · ETD
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 147d
Cleared Jun 14, 1990
BLOM-SINGER(R) TRACHEOESOPHAGEAL PUNCTURE KIT
K900518 · EWL
Helix Medical, Inc.
Ear, Nose, Throat · 132d
Cleared Jun 14, 1990
ARVEE APNEA MONITOR, MODEL 4800
K900730 · BZQ
Arvee Medical, Inc.
Anesthesiology · 119d
Cleared Jun 14, 1990
NUBALOO(R) SUNGLASSES
K901160 · HQY
Blublocker Corp.
Ophthalmic · 93d
Cleared Jun 14, 1990
(EYEGLASS) FRAMES AND SUNGLASSES
K901167 · HQY
Optique Marquis, Div. Sugerose, Inc.
Ophthalmic · 93d
Cleared Jun 14, 1990
INVOTEC BI-VALVE SPLINT
K901306 · LYA
Invotec International, Inc.
Ear, Nose, Throat · 86d
Cleared Jun 14, 1990
PASSAGE AIRWAY SPLINT
K901307 · LYA
Invotec International, Inc.
Ear, Nose, Throat · 86d
Cleared Jun 14, 1990
ULTRASTAT NASAL CATHETER
K901310 · EMX
Invotec International, Inc.
Ear, Nose, Throat · 86d
Cleared Jun 14, 1990
INVOTEC SEPTAL BUTTON
K901366 · LFB
Invotec International, Inc.
Ear, Nose, Throat · 83d
Cleared Jun 14, 1990
BARTON-MAYO TRACHEOSTOMA BUTTON
K901377 · KAC
Medical Innovations International, Inc.
Ear, Nose, Throat · 84d
Cleared Jun 14, 1990
RETRAX SAFETY SYRINGE
K901508 · FMF
Retrax, Inc.
General Hospital · 76d
Cleared Jun 14, 1990
LEG EEZE
K901931 · IRO
Jereva, Inc.
Physical Medicine · 45d
Cleared Jun 14, 1990
CUSTOM ITE HEARING AID MODELS C AND M
K902351 · ESD
Oticon Corp.
Ear, Nose, Throat · 16d
Cleared Jun 14, 1990
CUSTOM ITE HEARING AID MODEL: H
K902352 · ESD
Oticon Corp.
Ear, Nose, Throat · 16d
Cleared Jun 14, 1990
CUSTOM ITE HEARING AID MODELS F AND L
K902353 · ESD
Oticon Corp.
Ear, Nose, Throat · 16d
Cleared Jun 14, 1990
CARDIOTHORACIC RULER
K902378 · KPR
Devcom, Inc.
Radiology · 16d
Cleared Jun 13, 1990
MODULAR FLEXIBLE DRILLING SYSTEM
K901165 · HWE
Dalton Technology, Inc.
Orthopedic · 92d
Cleared Jun 13, 1990
DALTON TECHNOLOGY FLEXIBLE SCREWDRIVER
K901166 · HXX
Dalton Technology, Inc.
Orthopedic · 92d
Cleared Jun 13, 1990
TITAN APOLLO AND NOVA ADJUSTING TABLES
K902234 · INQ
Titan Tables
Physical Medicine · 27d
Cleared Jun 13, 1990
TITAN GLADIATOR ADJUSTING TABLE
K902549 · INQ
Titan Tables
Physical Medicine · 5d
Cleared Jun 12, 1990
AP900/PRP MODULE AND ACCESSORIES, MODIFICATION
K893218 · CAC
Electromedics, Inc.
Anesthesiology · 411d
Cleared Jun 12, 1990
SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM
K896467 · CHH
Medisense, Inc.
Chemistry · 211d
Cleared Jun 12, 1990
ACS ADVANCED CONCEPT GUIDE WIRE
K900386 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 134d