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
88561–88584 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 05, 1998
SILIMED VAGINAL STENT
K974479 · KXP
Silimed, LLC
Obstetrics & Gynecology · 252d
Cleared Aug 05, 1998
RESPAIDE
K980052 · CBP
Emergency Filtration Products, Inc.
Anesthesiology · 211d
Cleared Aug 05, 1998
NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR
K980148 · ETN
The Magstim Company , Ltd.
Ear, Nose, Throat · 202d
Cleared Aug 05, 1998
STAT-SIMPLE PYLORI
K980782 · LYR
Saliva Diagnostic Systems, Inc.
Microbiology · 156d
Cleared Aug 05, 1998
BARD QUANTUM SVR MODEL NUMBER H-6440VR
K981628 · DTN
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared Aug 05, 1998
S2LO
K981640 · HLI
Odyssey Optical Systems, LLC
Ophthalmic · 89d
Cleared Aug 05, 1998
STABLEMAPR STEERABLE INTRACARDIAC CATHETERS
K981642 · DRF
Medtronic Cardiorhythm
Cardiovascular · 89d
Cleared Aug 05, 1998
AUREX-3
K981704 · KLW
Adm Tronics Unltd, Inc.
Ear, Nose, Throat · 83d
Cleared Aug 05, 1998
SHELHIGH NO-REACT PNEUMOPLEDGETS
K981756 · FTL
Shelhigh, Inc.
General & Plastic Surgery · 79d
Cleared Aug 05, 1998
LIGHT SABER CORE TISSUE NEEDLE
K981796 · KNW
Minrad, Inc.
Gastroenterology & Urology · 76d
Cleared Aug 05, 1998
SILIMED TISSUE EXPANDER
K981852 · LCJ
Silimed, LLC
General & Plastic Surgery · 71d
Cleared Aug 05, 1998
UM-150A
K981908 · GEI
Umeco Union Medical Engineering
General & Plastic Surgery · 65d
Cleared Aug 05, 1998
KELOCATE SHEETING
K982051 · MDA
Allied Biomedical Corp.
General & Plastic Surgery · 55d
Cleared Aug 05, 1998
SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT
K982236 · CDQ
Sigma Diagnostics, Inc.
Chemistry · 41d
Cleared Aug 05, 1998
SMOKE EVACUATION ATTACHMENT 130XXX TBD
K982309 · GEI
Conmedcorp
General & Plastic Surgery · 35d
Cleared Aug 05, 1998
WIRELESS STANDARD PROBE, DYNAMIC REFERENCE FRAME (DRF)
K982364 · HAW
Radionics, Inc.
Neurology · 30d
Cleared Aug 05, 1998
DADE TRU-LIQUID CARDIAC CONTROL
K982591 · JJX
Dade Behring, Inc.
Chemistry · 12d
Cleared Aug 04, 1998
NASAL INTERFACE MODEL 7910
K974453 · BZD
Healthdyne Technologies, Inc.
Anesthesiology · 252d
Cleared Aug 04, 1998
SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR
K974648 · MOP
Sulzer Carbomedics, Inc.
Cardiovascular · 235d
Cleared Aug 04, 1998
ULTRACON/ULTRACON S RIGID GAS PERMEABLE CONTACT LENS FOR DAILY WEAR
K980197 · HQD
Specialty Ultravision, Inc.
Ophthalmic · 196d
Cleared Aug 04, 1998
DIVAN ANESTHESIA VENTILATOR
K980208 · CBK
Draeger Medical, Inc.
Anesthesiology · 196d
Cleared Aug 04, 1998
NARKOMED 6000 MODEL NUMBER NM6000
K980553 · BSZ
Draeger Medical, Inc.
Anesthesiology · 173d
Cleared Aug 04, 1998
SYNTHES SPINE PEDIATRIC ROD SYSTEM
K980761 · MNH
Synthes Spine
Orthopedic · 158d
Cleared Aug 04, 1998
FLO-THRU
K981624 · DXC
Bio-Vascular, Inc.
Cardiovascular · 89d