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
104689–104712 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 1995
TRU-TOUCH MEDICAL GLOVES
K944183 · LYZ
Bd Becton Dickinson Vacutainer...
General Hospital · 153d
Cleared Jan 26, 1995
CIT TWO WAY SUCTIN AND IRRIGATION TUBES
K944268 · HET
Chirurgische Instrumente
Obstetrics & Gynecology · 147d
Cleared Jan 26, 1995
ULTRASAFE ASPIRATING SYRINGE
K944425 · MEG
Safety Syringes, Inc.
General Hospital · 136d
Cleared Jan 26, 1995
I.V.I.D. FLUID ADMINISTRATION SET MARKER
K944619 · FPA
Advanced Bioresearch Assoc.
General Hospital · 128d
Cleared Jan 26, 1995
OPTUS SINUSCOPES AND ACCESSORIES
K944656 · EOB
Optus, Inc.
Ear, Nose, Throat · 127d
Cleared Jan 26, 1995
INTRASCAN II
K944771 · LMD
Markcare Medical Systems, Inc.
Radiology · 121d
Cleared Jan 26, 1995
BOTTLE COLLECTION SET
K945179 · HGF
Medgyn Products, Inc.
Obstetrics & Gynecology · 94d
Cleared Jan 26, 1995
DISPOSABLE SYRINGES AND DISPOSABLE NEEDLES
K945225 · FMF
Myco Medical Supplies, Inc.
General Hospital · 92d
Cleared Jan 26, 1995
HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH
K945248 · JEQ
Hukuba Dental Corp.
Dental · 91d
Cleared Jan 26, 1995
BIG PHIL
K946027 · FMI
Biomedical Waste Systems, Inc.
General Hospital · 48d
Cleared Jan 26, 1995
PULPDENT PERIODONTAL DRESSINGS
K946137 · EMA
Pulpdent Corp.
Dental · 41d
Cleared Jan 26, 1995
VIDEO ENDOSCOPE SYSTEM WITH ZOOM
K946171 · GCJ
Oktas
General & Plastic Surgery · 38d
Cleared Jan 26, 1995
BRIMFIELD PRECISION GRASPER/DISSECTOR
K946263 · GCJ
Springfield Surgical Instruments
General & Plastic Surgery · 34d
Cleared Jan 26, 1995
UNITRON MODEL SOUNG F/S
K946264 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 34d
Cleared Jan 26, 1995
PHONAK SONO-FORTE 332X-AZ
K946294 · ESD
Phonak, Inc.
Ear, Nose, Throat · 30d
Cleared Jan 26, 1995
CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE
K946307 · EBF
Confi-Dental Products Co.
Dental · 29d
Cleared Jan 25, 1995
GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER
K933818 · KDI
C.G.H. Medical, Inc.
Gastroenterology & Urology · 539d
Cleared Jan 25, 1995
TOMTEC ECHO-VIEW
K934139 · IYO
Tomtec Tomographic Technologies GmbH
Radiology · 518d
Cleared Jan 25, 1995
UTERINE MANIPULATOR/INJECTOR WITH SPRING
K941458 · LKF
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 306d
Cleared Jan 25, 1995
IL TEST CARBAMAZEPINE, PN 181754-00
K942687 · KLT
Instrumentation Laboratory CO
Toxicology · 232d
Cleared Jan 25, 1995
MODEL 578 MOBILE SURGICAL STRETCHER
K943969 · FPO
Hausted, Inc.
General Hospital · 163d
Cleared Jan 25, 1995
IL TEST GENTAMICIN CALIBRATORS
K943982 · LCD
Instrumentation Laboratory CO
Toxicology · 232d
Cleared Jan 25, 1995
ABUSCREEN ONTRAK POSITIVE CONTROL
K943999 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 187d
Cleared Jan 25, 1995
ANATOM 2000
K944131 · JAK
Analogic Corp.
Radiology · 154d