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
119281–119304 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 1991
DOBBHOFF(R) PERCUTANEOUS TRANSHEPAT BILIARY STENT
K913073 · FGE
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 106d
Cleared Oct 25, 1991
IPS EMPRESS
K913372 · EIH
Ivoclar North America, Inc.
Dental · 88d
Cleared Oct 25, 1991
TORQUE TUBE STEEROCATH(TM)
K913375 · DRF
Ep Technologies, Inc.
Cardiovascular · 88d
Cleared Oct 25, 1991
VENTREX COATED TUBE INTACT PTH
K913434 · CEW
Ventrex Laboratories, Inc.
Chemistry · 85d
Cleared Oct 25, 1991
ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20
K913466 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 81d
Cleared Oct 25, 1991
MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER
K913590 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 74d
Cleared Oct 25, 1991
CIBA CORNING ACS T3 IMMUNOASSAY
K913646 · CDD
Ciba Corning Diagnostics Corp.
Chemistry · 70d
Cleared Oct 25, 1991
FERNO ILLE HI-LO JR. MOBILE WHIRLPOOL, MODEL 403
K914125 · ILJ
Ferno
Physical Medicine · 42d
Cleared Oct 25, 1991
SCOPTOPIC SENSITIVITY TEST-1[SST-1]
K914163 · HLX
Lkc Technologies, Inc.
Ophthalmic · 38d
Cleared Oct 25, 1991
KPE 230 AM
K914172 · HQC
Ipax, Inc.
Ophthalmic · 60d
Cleared Oct 25, 1991
KPE 220 TS, NONSTERILE
K914221 · HQE
Ipax, Inc.
Ophthalmic · 63d
Cleared Oct 25, 1991
CLEARVIEW HCG SERUM/URINE PROFESS PREG TEST, MODIF
K914240 · JHI
Unipath , Ltd.
Chemistry · 51d
Cleared Oct 25, 1991
COX DISPOSABLE ENDOSCOPE CLEANING BRUSH
K914442 · FEB
Cox Medical Ent., Inc.
General Hospital · 21d
Cleared Oct 25, 1991
COX DISPOSABLE CYTOLOGY BRUSHES
K914466 · FDX
Cox Medical Ent., Inc.
Gastroenterology & Urology · 18d
Cleared Oct 25, 1991
VENTILATOR STAND
K914485 · CBK
Bird Products Corp.
Anesthesiology · 17d
Cleared Oct 24, 1991
CROSSLINK PLATE
K911307 · KWP
Danek Medical, Inc.
Orthopedic · 213d
Cleared Oct 24, 1991
EDITOR MP 800/HF-850 X-RAY CONTROL AND GENERATOR
K911562 · IZO
Continental X-Ray Corp.
Radiology · 199d
Cleared Oct 24, 1991
DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480
K911584 · IYO
Pie Medical Equipment B.V.
Radiology · 199d
Cleared Oct 24, 1991
POSTERIOR NASAL EPISTAXIS INSTRUMENTS
K911756 · ECB
Richard Wolf Medical Instruments Corp.
Dental · 189d
Cleared Oct 24, 1991
GRAVITRON UPPER BODY SYSTEM EXERCISER
K912056 · ISD
Tri-Tech, Inc.
Physical Medicine · 168d
Cleared Oct 24, 1991
4000 PT EXERCISE SYSTEM
K912057 · ISD
Tri-Tech, Inc.
Physical Medicine · 168d
Cleared Oct 24, 1991
GAUNTLET STAIR CLIMBER
K912058 · ISD
Tri-Tech, Inc.
Physical Medicine · 168d
Cleared Oct 24, 1991
OES THORACOSCOPE SYSTEM
K912362 · EWY
Olympus Corp.
Ear, Nose, Throat · 148d
Cleared Oct 24, 1991
TA620 TREADMILL CONTROLLER
K913518 · IOL
Siemens Burdick, Inc.
Physical Medicine · 78d