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
105049–105072 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 1994
AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM
K923273 · IYO
Acoustic Imaging Technologies Corp.
Radiology · 904d
Cleared Dec 27, 1994
MEDISON 4800
K925582 · IYO
Medison America, Inc.
Radiology · 782d
Cleared Dec 27, 1994
CONCEPTUS UTERINE CATHETER
K933723 · LKF
Conceptus, Inc.
Obstetrics & Gynecology · 512d
Cleared Dec 27, 1994
CERVICAL CATHETER
K933981 · LKF
Conceptus, Inc.
Obstetrics & Gynecology · 498d
Cleared Dec 27, 1994
DAIG DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER
K942379 · DRF
Daig Corp.
Cardiovascular · 232d
Cleared Dec 27, 1994
PSI FLEXIBLE ARM
K942601 · GCJ
V. Mueller Neuro/Spine
General & Plastic Surgery · 209d
Cleared Dec 27, 1994
VISUALIZER 2000
K943272 · JAA
Vf-Works, Inc.
Radiology · 173d
Cleared Dec 27, 1994
ACT-ONE ADVANCED COMPRESSION TECHNOLOGY FOOT PUMP
K943287 · JOW
Ndm Acquisition Corp.
Cardiovascular · 172d
Cleared Dec 27, 1994
PERSONAL HEARING SYSTEM
K944041 · LRS
Resound Corp.
General & Plastic Surgery · 131d
Cleared Dec 27, 1994
LIFESOUND MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS
K944174 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 123d
Cleared Dec 27, 1994
SOFT SOCK
K944240 · FQL
Silipos, Inc.
General Hospital · 117d
Cleared Dec 27, 1994
MO4 SERIES
K944404 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 110d
Cleared Dec 27, 1994
OLYMPUS MAGNESIUM REAGENT
K944407 · JGJ
Olympus America, Inc.
Chemistry · 110d
Cleared Dec 27, 1994
P/2000
K944411 · FNM
Plexus Medical
General Hospital · 110d
Cleared Dec 27, 1994
WIDEX MODEL LOGO 8S
K944518 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 102d
Cleared Dec 27, 1994
AIR CONDUCTION HEARING AID
K944520 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 102d
Cleared Dec 27, 1994
FAMILY OF PRIMUS FORCEPS: GRASPERS/DISSECTORS/SUTURERS/NEEDLE DRIVERS
K944563 · HET
Marlow Surgical Technologies, Inc.
Obstetrics & Gynecology · 99d
Cleared Dec 27, 1994
SIEMENS FRONTIER SERICE, MODELS S-1,S-2 AND S-3 MULTIPLE SITUATION, SINGLE...
K944645 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 97d
Cleared Dec 27, 1994
SUNRISE TECHNOLOGIES MODEL 5020 PLDD KIT
K944758 · GEX
Cardiogenes
General & Plastic Surgery · 95d
Cleared Dec 27, 1994
VTI DISPOSABLE PRESSURE DISPLAY SET
K944764 · DXS
Vascular Technology Incorporated
Cardiovascular · 91d
Cleared Dec 27, 1994
SKIN SCRUB TRAY
K944881 · FRG
Clinical Resources, Inc.
General Hospital · 85d
Cleared Dec 27, 1994
NERVE MONITOR ELECTRODES/STIMULATOR PROBES
K945242 · ETN
Micromed Development Corp.
Ear, Nose, Throat · 61d
Cleared Dec 27, 1994
MAMMOGRAPHIC X-RAY UNIT
K945496 · IZH
Lorad Corp.
Radiology · 49d
Cleared Dec 27, 1994
KXO-80G
K945668 · IZO
Toshiba America Medical Systems, In.C
Radiology · 40d