FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
91321–91344 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 23, 1997
INDIGO PORTABLE LASER SYSTEM WITH TEMPERATURE FEEDBACK -MODEL IDL 830 (POWER...
K963969 · GEX
Indigo Medical, Inc.
General & Plastic Surgery · 446d
Cleared Dec 23, 1997
COMPOUND SULPHONAMIDES ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971637 · JTN
Oxoid , Ltd.
Microbiology · 235d
Cleared Dec 23, 1997
3I BIORESORBABLE FIXATION TACK
K972480 · DZL
Implant Innovations, Inc.
Dental · 175d
Cleared Dec 23, 1997
LORAD M-III ELITE (M-III E)
K973631 · IZH
Lorad Corp.
Radiology · 90d
Cleared Dec 23, 1997
N.I.T., INC. NEEDLE GUIDING TEMPLATE
K973638 · IWJ
Avid N.I.T., Inc.
Radiology · 90d
Cleared Dec 23, 1997
FLOSTAT VASCULAR LAB
K973644 · JAF
Biomedix, Inc.
Radiology · 90d
Cleared Dec 23, 1997
DUODERM CONTROL GEL FORMULA BORDER DRESSING
K973688 · FRO
Convatec, Ltd.
General & Plastic Surgery · 88d
Cleared Dec 23, 1997
DUODERM HYDROACTIVE DRESSING
K973689 · FRO
Convatec, Ltd.
General & Plastic Surgery · 88d
Cleared Dec 23, 1997
MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASER
K973719 · GEX
Continuum Biomedical, Inc.
General & Plastic Surgery · 84d
Cleared Dec 23, 1997
HARMONIC IMAGING WITH CONTRAST
K973767 · IYO
Acuson Corp.
Radiology · 82d
Cleared Dec 23, 1997
DUODERM HYDROACTIVE PASTE
K973807 · FRO
Convatec, A Bristol-Myers Squibb Co.
General & Plastic Surgery · 78d
Cleared Dec 23, 1997
LEVO COMPACT-EASY LCE
K973951 · IPL
Levo USA
Physical Medicine · 68d
Cleared Dec 23, 1997
INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
K974048 · KPI
Hollister, Inc.
Gastroenterology & Urology · 60d
Cleared Dec 23, 1997
DISTAL CENTRALIZER, EXETER II HIP SYSTEM
K974054 · JDI
Howmedica, Inc.
Orthopedic · 57d
Cleared Dec 23, 1997
SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA
K974306 · CEW
Sangui Biotech, Inc.
Chemistry · 36d
Cleared Dec 22, 1997
DAXOR MAX100 SYRINGE (MAX100)
K970419 · FMF
Daxor Corporation
General Hospital · 321d
Cleared Dec 22, 1997
GE LOGIQ 500 DIAGNOSTIC ULTRASOUND SYSTEM
K970901 · IYO
GE Medical Systems
Radiology · 286d
Cleared Dec 22, 1997
SYNTEX
K971360 · LYZ
Shinemound Enterprise, Inc.
General Hospital · 255d
Cleared Dec 22, 1997
NIPRO CORELESS NEEDLE/CORELESS NEEDLE SET
K971582 · LJT
Nipro Medical Corp.
General Hospital · 236d
Cleared Dec 22, 1997
ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM
K972406 · GOD
Immunoprobe, Inc.
Microbiology · 179d
Cleared Dec 22, 1997
CATHETER TUNNELER
K972555 · LJS
Gerard Medical, Inc.
General Hospital · 168d
Cleared Dec 22, 1997
SYVEK PATCH
K972914 · KGX
Marine Polymer Technologies, Inc.
General & Plastic Surgery · 137d
Cleared Dec 22, 1997
SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT...
K973513 · EBF
Espe GmbH & Co. Kg.
Dental · 96d
Cleared Dec 22, 1997
DUODERM CGF CONTROL GEL FORMULA DRESSING
K973632 · FRO
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 89d