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
147097–147120 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 19, 1985
CARIO-PACE DURAPULSE P101 COATED PULSE GENERATOR
K853425 · DXY
Cardio-Pace Medical, Inc.
Cardiovascular · 5d
Cleared Aug 16, 1985
ICP MONITOR MODEL 1000
K844566 · GWM
Advanced Ultrasonic Testing &...
Neurology · 266d
Cleared Aug 16, 1985
PTCA GUIDING CATHETER
K851947 · DYB
Cordis Corp.
Cardiovascular · 105d
Cleared Aug 16, 1985
FLUSH DEVICE, AUTOMATIC
K851987 · DRS
Transamerica Delaval, Inc.
Cardiovascular · 101d
Cleared Aug 16, 1985
ADMINISTRATION SET
K851988 · DRS
Transamerica Delaval, Inc.
Cardiovascular · 101d
Cleared Aug 16, 1985
HEARING AID(ALL IN THE EAR(ALL IN THE CANAL
K852052 · ESD
Penn-Tech Laboratories
Ear, Nose, Throat · 99d
Cleared Aug 16, 1985
DAHLBERG MODEL US SPECTRUM IN-THE-EAR HEARING AID
K852098 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 93d
Cleared Aug 16, 1985
THE P.C.A. TWO-PIECE SNAP LOCK ACETABULAR CUP
K852153 · JDI
Howmedica Corp.
Orthopedic · 91d
Cleared Aug 16, 1985
CRAFTEMP ET 3045 ELECTRONIC THERMOMETRY SYSTEM
K852454 · FLL
Gambro, Inc.
General Hospital · 67d
Cleared Aug 16, 1985
WALDMANN F85/100W PUVA
K852575 · KGL
Sylvania Lighting Products
General & Plastic Surgery · 59d
Cleared Aug 16, 1985
CDSA(COLOR DENSITY, SPECTRAL ARRRAY)
K852587 · OLT
Tracor Northern, Inc.
Neurology · 59d
Cleared Aug 16, 1985
CHARACTERIZER KIT VISIBLE LIGHT CURED RESTOR-COLOR
K852744 · EBF
The S. S. White Co.
Dental · 50d
Cleared Aug 16, 1985
PORCELAIN VENEER SYSTEM BONDING KIT
K852745 · EBF
The S. S. White Co.
Dental · 50d
Cleared Aug 16, 1985
BAG DECANTER
K852777 · KPE
Advance Medical Designs, Inc.
General Hospital · 46d
Cleared Aug 16, 1985
BOTTLE DECANTER
K852778 · KPE
Advance Medical Designs, Inc.
General Hospital · 46d
Cleared Aug 16, 1985
VENTED SECONDARY IV ADMINISTRATION SET
K852881 · FPA
Lyphomed, Inc.
General Hospital · 38d
Cleared Aug 16, 1985
MAXIFILL TRANSFER SET
K852882 · LHI
Lyphomed, Inc.
General Hospital · 38d
Cleared Aug 16, 1985
PREFORMED TOOTH ARCH
K852981 · ELM
Swipes Dental Laboratory
Dental · 32d
Cleared Aug 16, 1985
BISFIL-M(LIGHT CURABLE ANTERIOR COMPOSITE)
K853001 · EBF
Bisco, Inc.
Dental · 31d
Cleared Aug 16, 1985
BISFIL-II(CHEMICAL CURABLE POSTERIOR/ANTERIOR)
K853002 · EBF
Bisco, Inc.
Dental · 31d
Cleared Aug 16, 1985
INTEGRITY
K853052 · EBG
Dentsply Intl.
Dental · 28d
Cleared Aug 16, 1985
CLICK LOCK MULTI-VAS INFECTION CONTROL MANIFOLD
K853275 · FMG
Icu Medical, Inc.
General Hospital · 11d
Cleared Aug 16, 1985
MULTICAP MULTIGAS CAPNOMETER PB252
K853396 · CCK
Instrumentarium Corp.
Anesthesiology · 4d
Cleared Aug 15, 1985
MONARCH STERILIZATION CONTAINER SYSTEM
K850289 · FRG
Monarch Products, Inc.
General Hospital · 203d