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
109585–109608 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 1994
ACETABULAR SHELL
K935731 · LPH
Howmedica Corp.
Orthopedic · 92d
Cleared Mar 03, 1994
INSTRUMENT TRAY
K935743 · LRO
Cush Medical Products
General & Plastic Surgery · 92d
Cleared Mar 03, 1994
CEDIA T4 MAB ASSAY MODIFICATION
K935880 · KLI
Microgenics Corp.
Chemistry · 87d
Cleared Mar 03, 1994
PROSCOPES AND ADSCOPES
K935944 · LDE
American Diagnostic Corp.
Cardiovascular · 80d
Cleared Mar 03, 1994
DERMASSIST PETROLATUM GAUZE,USP
K936230 · FRO
Wilshire Medical Products
General & Plastic Surgery · 64d
Cleared Mar 03, 1994
DERMASSIST OIL EMULSION NON-ADHERING WOUND DRESSING
K936234 · FRO
Wilshire Medical Products
General & Plastic Surgery · 64d
Cleared Mar 03, 1994
ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY
K940005 · CGJ
Bio-Rad Laboratories, Inc.
Chemistry · 59d
Cleared Mar 03, 1994
DERMASSIST WET DRESSING, SALINE
K940044 · FRO
Wilshire Medical Products
General & Plastic Surgery · 57d
Cleared Mar 03, 1994
DERMASSIST WET DRESSING, WATER
K940076 · FRO
Wilshire Medical Products
General & Plastic Surgery · 56d
Cleared Mar 02, 1994
CRYOBAG
K915471 · LPZ
Janus Biomedical, Inc.
General Hospital · 817d
Cleared Mar 02, 1994
CORDIS POLYPROPYLENE BURR HOLE RESERVOIR
K925810 · JXG
Cordis Corp.
Neurology · 470d
Cleared Mar 02, 1994
KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+
K930149 · HEB
Kimberly-Clark Corp.
Obstetrics & Gynecology · 414d
Cleared Mar 02, 1994
VCI INSUFLATOR FILTER W/ TUBING
K930192 · HIF
Vital Concepts, Inc.
Obstetrics & Gynecology · 412d
Cleared Mar 02, 1994
LI VASECTOMY
K932465 · KOA
Femcare , Ltd.
Gastroenterology & Urology · 285d
Cleared Mar 02, 1994
SPACELABS MEDICAL MODEL 90481 EEG MODULE
K932842 · GWQ
Spacelabs Medical, Inc.
Neurology · 264d
Cleared Mar 02, 1994
RQM-1005 INTEGULASER RUBY MEDICAL LASER SYSTEM
K933140 · GEX
Laser Photonics, Inc.
General & Plastic Surgery · 247d
Cleared Mar 01, 1994
CARDIOFAX Q ECG-8420A
K922394 · LOS
Nihon Kohden America, Inc.
Cardiovascular · 650d
Cleared Mar 01, 1994
TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST
K922496 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 643d
Cleared Mar 01, 1994
OPTILASE ND:YAG MODELS 1000/4000 SURG LASER SYSTEM
K922497 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 643d
Cleared Mar 01, 1994
TENS DEVICE FOR RELIEF OF CHRONIC PAIN, MODIFIED
K924876 · GZT
Graham-Field, Inc.
Neurology · 524d
Cleared Mar 01, 1994
ELECTROSURGICAL ELECTRODE
K925116 · EKZ
Premier
Dental · 508d
Cleared Mar 01, 1994
TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASE SYST
K925124 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 504d
Cleared Mar 01, 1994
IT-7 FEMORAL COMPONENT, ANATOMIC HIP SYSTEM
K925153 · KWY
Howmedica Corp.
Orthopedic · 504d
Cleared Mar 01, 1994
LATERALASE CATHETER
K925414 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 491d