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
146377–146400 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 1985
KAY PLUS ADULT DIAPER
K853740 · EYQ
Beghin_Say Intl., Inc.
Gastroenterology & Urology · 41d
Cleared Oct 17, 1985
TECHNA VISION, INC. ELECTRIC CHAIR
K853743 · HME
Techna Vision
Ophthalmic · 41d
Cleared Oct 17, 1985
TECHNA VISION, INC.ELECTRIC TABLE
K853744 · HRJ
Techna Vision
Ophthalmic · 41d
Cleared Oct 17, 1985
COBE REN NEW-D DISPENSING KIT
K853817 · LIF
Cobe Laboratories, Inc.
Gastroenterology & Urology · 35d
Cleared Oct 16, 1985
INTERFACE MODULES IM 1000 IMAGE COMMUNI-NETWORK
K850417 · LMD
Impact Systems Corp.
Radiology · 254d
Cleared Oct 16, 1985
NAIL SPLINT
K850803 · MQZ
Inro Medical Designs, Inc.
General & Plastic Surgery · 231d
Cleared Oct 16, 1985
VENTREZYME, VAST IMMUNOPEROXIDASE ASSAY
K850895 · DHB
Ventrex Laboratories, Inc.
Immunology · 226d
Cleared Oct 16, 1985
DENTAL PORCELAIN-VARIOUS
K851733 · ELL
Excelco Intl., Inc.
Dental · 174d
Cleared Oct 16, 1985
HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT
K851976 · GMM
Si Sero-Immuno Diagnostics, Inc.
Microbiology · 162d
Cleared Oct 16, 1985
HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT
K851977 · GMM
Si Sero-Immuno Diagnostics, Inc.
Microbiology · 162d
Cleared Oct 16, 1985
FLEXIROOT
K852305 · DZE
Facial Alveodental Implant...
Dental · 140d
Cleared Oct 16, 1985
DOWNS VPAP CIRCUIT
K852333 · CAN
Vital Signs, Inc.
Anesthesiology · 138d
Cleared Oct 16, 1985
PHARMA-PLAST CLINIPAK
K852443 · FMF
Pharma-Plast USA, Inc.
General Hospital · 128d
Cleared Oct 16, 1985
ASIK 'ONCE' SYRINGE
K852444 · FMF
Pharma-Plast USA, Inc.
General Hospital · 128d
Cleared Oct 16, 1985
DOUBLE PUNCTURE INSTRUMENTS
K852901 · HET
L.A.S.E.R., Inc.
Obstetrics & Gynecology · 99d
Cleared Oct 16, 1985
KNEE MACHINE
K852977 · BXB
Kaiser Medical
Physical Medicine · 93d
Cleared Oct 16, 1985
MEDNOVA SAFETY BAG
K853075 · LHI
Mednova Corp.
General Hospital · 85d
Cleared Oct 16, 1985
STORZ SOLID-STANDOFF PACHYMETRY PROBE
K853087 · IYO
Storz Instrument Co.
Radiology · 85d
Cleared Oct 16, 1985
COOPER LASER SONICS CUSA MODEL 200
K853143 · LBK
Cooper Lasersonics, Inc.
Neurology · 79d
Cleared Oct 16, 1985
CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036
K853144 · KTN
Preco, Inc.
Immunology · 79d
Cleared Oct 16, 1985
BOEHRINGER LAB SUCTION INTERRUPTER
K853155 · KDP
Boehringer Laboratories
General Hospital · 79d
Cleared Oct 16, 1985
ENDODONTIC ELECTRONIC SPREADER HEATER
K853183 · EKK
Sturgeon Engineering Co.
Dental · 78d
Cleared Oct 16, 1985
TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER
K853245 · EWO
Tracor Instruments, Inc.
Ear, Nose, Throat · 76d
Cleared Oct 16, 1985
J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO
K853251 · DTZ
Johnson & Johnson Professionals, Inc.
Cardiovascular · 79d