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
126721–126744 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 1990
MRT 50A SOFTWARE RELEASE 9.0
K900283 · LNH
Toshiba America Mri, Inc.
Radiology · 56d
Cleared Mar 19, 1990
HYCULT DIAMOND CORONARY BYPASS KNIFE
K900379 · DWS
St. Jude Medical, Inc.
Cardiovascular · 52d
Cleared Mar 19, 1990
WATER JEL STERILE GEL-SOAKED BURN DRESSING
K900516 · FRO
Trilling Medical Technologies, Inc.
General & Plastic Surgery · 45d
Cleared Mar 19, 1990
CLASSIC ECG/STIMULATING NO. 1700 SERIES
K900519 · DRX
Classic Medical Products, Inc.
Cardiovascular · 45d
Cleared Mar 19, 1990
SWIVEL ADAPTER
K900642 · HHI
Williams Specialty Products, Inc.
Obstetrics & Gynecology · 38d
Cleared Mar 19, 1990
IRON LIQUID STABLE REAGENT
K900902 · JIY
Medical Analysis Systems, Inc.
Chemistry · 20d
Cleared Mar 19, 1990
ANTI-RNP MICROASSAY
K901073 · LLL
Diamedix Corp.
Immunology · 11d
Cleared Mar 16, 1990
STAT-TRACH(TM) VENTILATION CATHETER
K894096 · BTO
Statron Corp.
Anesthesiology · 280d
Cleared Mar 16, 1990
MODIFIED STAR CALC
K895963 · BZC
Infrasonics Corp.
Anesthesiology · 156d
Cleared Mar 16, 1990
OLYMPUS HYSTERORESECTOSCOPE
K897003 · HIH
Olympus Corp.
Obstetrics & Gynecology · 88d
Cleared Mar 16, 1990
BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE
K897005 · JOH
Helix Medical, Inc.
Anesthesiology · 88d
Cleared Mar 16, 1990
PICSO CANNULA, CATALOG CODE 94315
K897022 · DWF
Dlp, Inc.
Cardiovascular · 87d
Cleared Mar 16, 1990
OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID
K897023 · LRB
Audina Hearing Instrument
Ear, Nose, Throat · 87d
Cleared Mar 16, 1990
SARNS MINIPRIME CARDIOPLEGIA SET W/CONDUCER(TM)
K897039 · DTR
3M Company
Cardiovascular · 88d
Cleared Mar 16, 1990
HEMAQUET(TM) AND HEMAFLEX(TM) INTRODUCERS
K897041 · DYB
C.R. Bard, Inc.
Cardiovascular · 88d
Cleared Mar 16, 1990
GIBSON ENDOLYMPHATIC SHUNT
K897049 · ESZ
Hood Laboratories
Ear, Nose, Throat · 88d
Cleared Mar 16, 1990
MILLER PERCUTANEOUS ANGIOGRAPHIC/SCOPIC IRRI. CATH
K897051 · DQO
Cathlab Corp.
Cardiovascular · 88d
Cleared Mar 16, 1990
THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM
K897057 · BYH
Thayer Medical Corp.
Anesthesiology · 88d
Cleared Mar 16, 1990
CENTURION VAGINAL SPECULUM
K897100 · HIC
Tri-State Hospital Supply Corp.
Obstetrics & Gynecology · 85d
Cleared Mar 16, 1990
SYSTEM TEN MODEL 100 SURGICAL SYSTEM
K900003 · JDX
Advanced Osseous Technologies
Orthopedic · 73d
Cleared Mar 16, 1990
H.E.A.R.T. NEBULIZER
K900228 · CAF
B&B Medical Technologies, Inc.
Anesthesiology · 58d
Cleared Mar 16, 1990
NASAL E.T. TAPE
K900787 · CBH
B&B Medical Technologies, Inc.
Anesthesiology · 24d
Cleared Mar 16, 1990
GAS SAMPLING NASAL CANNULA
K900979 · CCK
Gibeck, Inc.
Anesthesiology · 14d
Cleared Mar 16, 1990
COMPUTERIZED FUNCTIONAL TESTING GAIT SYSTEM
K901069 · KHX
Computerized Functional Testing Corp.
Physical Medicine · 9d