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
114769–114792 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 1993
WRIST TRACTION
K926069 · KPR
Octostop, Inc.
Radiology · 51d
Cleared Jan 15, 1993
DIOMED 25 SURGICAL DIODE LASER, GEN SURG APPLICAT
K914521 · GEX
Dio-Med Corp.
General & Plastic Surgery · 463d
Cleared Jan 15, 1993
CIRCON ACMI GEN SURG INSTRU FOR MINI INVASIVE SURG
K914883 · GEI
Circon Video
General & Plastic Surgery · 443d
Cleared Jan 15, 1993
HEATED RESPIRATORY HUMIDIFIER HC100
K915460 · BTT
Fisher & Paykel Electronics , Ltd.
Anesthesiology · 408d
Cleared Jan 15, 1993
PHYSIOLOGICAL MEASUREMENT AND DISPLAY SYSTEMS
K920587 · DQK
Siemens Medical Solutions USA, Inc.
Cardiovascular · 340d
Cleared Jan 15, 1993
PRIME PCA AND PCA/CONTINUOUS SYSTEMS
K920637 · MEA
Prime Medical Products, Inc.
General Hospital · 338d
Cleared Jan 15, 1993
NEO-STAT DIALYSATE METER
K920810 · FIZ
Automata Medical Instrumentation, Inc.
Gastroenterology & Urology · 329d
Cleared Jan 15, 1993
SESQUIPOLAR(TM) MIS ELECTRODE
K922289 · GEI
Beacon Laboratories, Inc.
General & Plastic Surgery · 245d
Cleared Jan 15, 1993
THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO
K922383 · EWO
Monitor Instruments, Inc.
Ear, Nose, Throat · 240d
Cleared Jan 15, 1993
FUKUDA DENSHI MODEL SPIROSIFT SP-5000
K922428 · BZG
Fukuda Denshi USA, Inc.
Anesthesiology · 238d
Cleared Jan 15, 1993
THERAPAX DXT 300 SERIES 3
K923584 · JAD
Oldelft Corp. of America
Radiology · 179d
Cleared Jan 15, 1993
SCOTTY
K923650 · CAW
Mountain Medical Equipment, Inc.
Anesthesiology · 178d
Cleared Jan 15, 1993
IVAC SYRINGE PUMP - 740 SERIES
K923981 · FRN
Y
General Hospital · 161d
Cleared Jan 15, 1993
CYTOQUANT COMBINED TRANSPORT MEDIA
K924053 · LIO
Proteins Intl., Inc.
Microbiology · 156d
Cleared Jan 15, 1993
CANDELA LASSER SYSTEMS MODIFIED
K924158 · GEX
Candela Laser Corp.
General & Plastic Surgery · 150d
Cleared Jan 15, 1993
MWX-7440 HIGH SPEED BUCKY
K924423 · KPX
Midwest X-Ray Equipment Co.
Radiology · 136d
Cleared Jan 15, 1993
SOFTWARE VERSION A2.5 FOR MAGNETOM 42SP/63SP SYST
K924489 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 134d
Cleared Jan 15, 1993
NEW DETECTOR FOR TRANSCAM/POLARIS S315
K924639 · IYX
Adac Laboratories
Radiology · 135d
Cleared Jan 15, 1993
FISK HEADREST
K924700 · FQO
Rhino Mfg.
General & Plastic Surgery · 120d
Cleared Jan 15, 1993
EXCEL TRIPULSE MODEL3000
K924729 · GEX
Excel Tech. , Ltd.
General & Plastic Surgery · 116d
Cleared Jan 15, 1993
SIM/PLANT
K924810 · JAK
Columbia Scientific, Inc.
Radiology · 112d
Cleared Jan 15, 1993
NEW DETECTOR OPTION
K924878 · IYX
Adac Laboratories
Radiology · 136d
Cleared Jan 15, 1993
MICROSPORIDIUM CONTROL SLIDE
K924893 · LJG
Scientific Device Laboratory, Inc.
Microbiology · 109d
Cleared Jan 15, 1993
CATHSCANNER VISIONS MICRORAIL ULTRA IMAG CATH
K924980 · ITX
Endosonics Corp.
Radiology · 106d