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
96649–96672 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 1996
MUREX RUB-EX
K954920 · LQN
Murex Diagnostics, Inc.
Microbiology · 300d
Cleared Aug 21, 1996
BBL MGIT PRODUCTS
K954932 · MDB
Becton Dickinson Diagnostic...
Microbiology · 299d
Cleared Aug 21, 1996
CARDIOCATH CATHETERIZATION LAB SYSTEM
K960321 · DPS
Prucka Engineering, Inc.
Cardiovascular · 212d
Cleared Aug 21, 1996
LASERSONICS ND:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABLE FIBER
K960636 · GEX
Heraeus Surgical, Inc.
General & Plastic Surgery · 189d
Cleared Aug 21, 1996
DIALYSIS MIXING & HOLDING TANK
K961416 · FIN
Dial Medical Supply
Gastroenterology & Urology · 131d
Cleared Aug 21, 1996
BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS
K961792 · DHA
Biocircuits Corp.
Chemistry · 104d
Cleared Aug 21, 1996
THE ROBOGUIDE
K961849 · IZH
Shai Syg Motion and Innovations, Ltd.
Radiology · 100d
Cleared Aug 21, 1996
ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER
K962012 · EWO
Ethical Hearing Instruments
Ear, Nose, Throat · 90d
Cleared Aug 21, 1996
PRONEB TURBO COMPRESSOR MODEL 38V0200
K962072 · CAF
Pari Holding Co.
Anesthesiology · 85d
Cleared Aug 21, 1996
BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)
K962174 · DTB
Intermedics, Inc.
Cardiovascular · 77d
Cleared Aug 21, 1996
IMMAGE IMMUNOCHEMISTRY SYSTEM
K962294 · JQX
Beckman Instruments, Inc.
Chemistry · 68d
Cleared Aug 21, 1996
3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM...
K962750 · IXW
Imation Corp.
Radiology · 37d
Cleared Aug 21, 1996
SHARPLAN LASERS, INC. AF ACUSPOT MICROMANIPULATOR (713)
K962974 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 21d
Cleared Aug 20, 1996
ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)
K951853 · LDJ
Tcpi, Inc.
Toxicology · 487d
Cleared Aug 20, 1996
POWDERFREE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM
K953955 · LYY
Codan Medlon, Inc.
General Hospital · 371d
Cleared Aug 20, 1996
BLUE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM
K953956 · LYY
Codan Medlon, Inc.
General Hospital · 371d
Cleared Aug 20, 1996
POWDERFREE BLUE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM
K953958 · LYY
Codan Medlon, Inc.
General Hospital · 371d
Cleared Aug 20, 1996
STRYKER ORAL MAX SYSTEM
K954690 · DZI
Stryker Corp.
Dental · 314d
Cleared Aug 20, 1996
EP-X BIPLANE
K961207 · JAA
Fischer Imaging Corp.
Radiology · 146d
Cleared Aug 20, 1996
TALKING DIGITAL THERMOMETER
K962369 · FLL
Ultmost Industrial Corp.
General Hospital · 62d
Cleared Aug 20, 1996
SENSOR SHEATH TS1
K962386 · FLL
Radiotherapeutics Corp.
General Hospital · 61d
Cleared Aug 20, 1996
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT)
K962485 · EOQ
Olympus America, Inc.
Ear, Nose, Throat · 55d
Cleared Aug 20, 1996
PERMARIDGE SYRINGE
K962838 · LYC
Ceramed Corp.
Dental · 29d
Cleared Aug 20, 1996
OLYMPUS B5-2C/B7-2C BALLOON CATHETER
K962901 · EOQ
Olympus America, Inc.
Ear, Nose, Throat · 26d