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
117505–117528 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 07, 1992
BIOLEX WOUND GEL,
K920050 · MGQ
Catalina Biomedical Corp.
General & Plastic Surgery · 92d
Cleared Apr 07, 1992
FLEXICAIR LOW AIRLOSS THERAPY UNIT
K920382 · IOQ
Support Systems Intl.
Physical Medicine · 68d
Cleared Apr 07, 1992
DESERET GUIDEWIRE INTRODUCER II
K920407 · DQO
Bd Becton Dickinson Vacutainer...
Cardiovascular · 67d
Cleared Apr 07, 1992
DESERET GUIDEWIRE INTRODUCER III
K920408 · DQO
Bd Becton Dickinson Vacutainer...
Cardiovascular · 67d
Cleared Apr 07, 1992
MAT TABLE, 8100 SERIES MAT PLATFORM
K920585 · INQ
Tri W-G, Inc.
Physical Medicine · 57d
Cleared Apr 07, 1992
HUMAN CHORIONIC GONADATROPHIN AND UNCON. ESTRIOL
K920826 · JJY
Eastman Kodak Company
Chemistry · 43d
Cleared Apr 07, 1992
TMB CHROMOGEN/SUBSTRATE REAGENT SET
K920918 · JHI
Bio Clinic Co.
Chemistry · 39d
Cleared Apr 07, 1992
VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY
K920952 · DBF
Vitek Systems, Inc.
Immunology · 41d
Cleared Apr 07, 1992
THE EXCELSIOR
K921084 · IPL
Rehab Technology, Inc.
Physical Medicine · 32d
Cleared Apr 07, 1992
WOM LAPAROFLATOR ELECTRONIC
K921086 · GCJ
W.O.M. GmbH
General & Plastic Surgery · 32d
Cleared Apr 07, 1992
ACTIVITY CHAIR
K921272 · INN
Rifton Equipment For the Handicapped
Physical Medicine · 21d
Cleared Apr 06, 1992
MEROCEL(R) LASER-GUARD(TM)
K910463 · BTR
Merocel Corp.
Anesthesiology · 437d
Cleared Apr 06, 1992
KAY-MED SURGICAL DEAPE/DRAP ACCESSORIES
K914761 · KKX
Kayco Medical, Inc.
General Hospital · 167d
Cleared Apr 06, 1992
500 INFUSER
K914988 · FRN
Excel Medical, Inc.
General Hospital · 152d
Cleared Apr 06, 1992
LAP TISSUE COLLECTION BAG
K915286 · GCJ
Baxter Healthcare Corp
General & Plastic Surgery · 133d
Cleared Apr 06, 1992
VORTECH'S FILM DIGITIZER, FD-1
K915362 · KPR
Vortech Data, Inc.
Radiology · 131d
Cleared Apr 06, 1992
HDRS-1 SYSTEM
K915367 · JAQ
Precision Radiation Measurement, Inc.
Radiology · 131d
Cleared Apr 06, 1992
MANUAL SURGICAL INSTRMENTS FOR LAPAROSCOPY
K915372 · GCJ
Unisurge, Inc.
General & Plastic Surgery · 131d
Cleared Apr 06, 1992
DESERET POSITIONAL SUTURE WING
K915495 · KMK
Bd Becton Dickinson Vacutainer...
General Hospital · 119d
Cleared Apr 06, 1992
ARJO CENTURY SCALES WITH REMOTE
K920074 · FRW
Arjo-Century, Inc.
General Hospital · 90d
Cleared Apr 06, 1992
CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATOR
K920114 · HIF
Spiess Design, Inc.
Obstetrics & Gynecology · 87d
Cleared Apr 06, 1992
MRT-50 FLEXIBLE BODY COIL
K920126 · LNH
Toshiba America Mri, Inc.
Radiology · 87d
Cleared Apr 06, 1992
OPTI-MOL FILTERED PUNCTURE PIN
K920306 · BTT
Automatic Liquid Packaging, Inc.
Anesthesiology · 75d
Cleared Apr 06, 1992
MU125M MOBILE X-RAY SYSTEM
K920393 · IZG
Shimadzu Medical Systems
Radiology · 67d