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
102313–102336 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 1995
ISOLYSER SHARPS MANAGEMENT SYSTEM SMS
K943626 · FMI
Thantex Specialties, Inc.
General Hospital · 325d
Cleared Jun 16, 1995
DINAMAP PLUS VITAL SIGNS MONOITOR
K943709 · DPS
Critikon Company, LLC
Cardiovascular · 319d
Cleared Jun 16, 1995
MODEL #5000 PULMO PLUS
K946039 · BTI
International Medical Systems
Anesthesiology · 186d
Cleared Jun 16, 1995
CARDICO SHARPS CONTAINERS (1.5, 5, 9, 13, 21QTS.)
K946041 · FMI
Cardico, Inc.
General Hospital · 186d
Cleared Jun 16, 1995
NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS
K950499 · KNF
American Hydro-Surgical Instruments,...
Obstetrics & Gynecology · 130d
Cleared Jun 16, 1995
OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT
K950521 · KWS
Osteonics Corp.
Orthopedic · 130d
Cleared Jun 16, 1995
SYSTEM 12 P1 26MM ACETABULAR INSERT
K951114 · LPH
Howmedica Corp.
Orthopedic · 98d
Cleared Jun 16, 1995
HOWMEDICA VITALOCK 22MM ACERTABULAR SHELL AND SYSTEM 12 INSERTS
K951115 · LPH
Howmedica Corp.
Orthopedic · 98d
Cleared Jun 16, 1995
PULSE KLYSTRON AMPLIFIER (L-5822-00)
K951142 · IYE
Litton Systems, Inc.
Radiology · 95d
Cleared Jun 16, 1995
SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER
K951304 · HWC
Synthes (Usa)
Orthopedic · 86d
Cleared Jun 16, 1995
PULSE*SPRAY INFUSION SYSTEM
K951509 · QEY
Angiodynamics, Div. E-Z-Em, Inc.
Cardiovascular · 74d
Cleared Jun 16, 1995
WOODBINE/SOLOS VCM-3, HIGH RESOLUTION ONE-CHIP SURGICAL CAMERA
K951522 · GCJ
Woodbine Optical Corp.
General & Plastic Surgery · 74d
Cleared Jun 16, 1995
SPYROFOAM WOUND DRESSING
K951730 · KMF
Polymedica Industries, Inc.
General & Plastic Surgery · 63d
Cleared Jun 16, 1995
C-FLEX ENDOLYMPHATIC SHUNT
K952227 · ESZ
Trebay Medical Corp.
Ear, Nose, Throat · 35d
Cleared Jun 16, 1995
CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628
K952233 · EAK
Victoreen, Inc.
Radiology · 35d
Cleared Jun 16, 1995
AURIUM 68M
K952402 · EJT
Argen Precious Metals, Inc.
Dental · 25d
Cleared Jun 16, 1995
IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
K952456 · JAA
Fisher Imaging Corp.
Radiology · 22d
Cleared Jun 16, 1995
RICHARDS PORP
K952481 · ETB
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 17d
Cleared Jun 16, 1995
VS1 PLUS
K952499 · EJT
Metalor Dental USA Corp.
Dental · 17d
Cleared Jun 16, 1995
S-SCORT
K952632 · BTA
Sscor
General & Plastic Surgery · 8d
Cleared Jun 15, 1995
STAINLESS STEEL GREEN VENA CAVA FILT W/12F INTR SY
K912035 · DTK
Boston Scientific Corp
Cardiovascular · 1498d
Cleared Jun 15, 1995
MEDRAD ENVISION CT INJECTOR AND QWIK FIT SYRINGE
K934086 · DXT
Medrad, Inc.
Cardiovascular · 660d
Cleared Jun 15, 1995
MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS
K943571 · DAP
More Diagnostics
Hematology · 331d
Cleared Jun 15, 1995
B-D DIGITAL THERMOMETER
K945427 · LHD
Bd Becton Dickinson Vacutainer...
Obstetrics & Gynecology · 223d