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
112513–112536 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 29, 1993
MULTIVIEW FOR WINDOWS
K931292 · LMD
Image Data Corp.
Radiology · 139d
Cleared Jul 29, 1993
USCI ANGIOGRAPHIC CATHETER
K932092 · DQO
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared Jul 29, 1993
BIRD AVIAN PORT MILITARY VENT NSN 6530-01-374-8903
K933262 · CBK
Bird Products Corp.
Anesthesiology · 23d
Cleared Jul 28, 1993
SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)
K915363 · KFM
3M Health Care, Ltd.
Cardiovascular · 609d
Cleared Jul 28, 1993
PORT ACCESS NEEDLE
K921902 · LJT
Kawasumi Laboratories Co., Ltd.
General Hospital · 462d
Cleared Jul 28, 1993
EMPTY SOLUTION TRANSFER CONTAINER W/ DETACH LEG
K923448 · KPE
Healthtek, Inc.
General Hospital · 379d
Cleared Jul 28, 1993
TRIGLYCERIDES GPO-PAP
K923508 · CDT
Randox Laboratories, Ltd.
Chemistry · 378d
Cleared Jul 28, 1993
PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS
K924337 · GCX
Deknatel, Inc.
General Hospital · 335d
Cleared Jul 28, 1993
VITAL-PORT VASC ACCESS 901OP/911OP/9012P/9112P
K924748 · LJT
Med Institute, Inc.
General Hospital · 309d
Cleared Jul 28, 1993
PNEUMATIC IRRIGATION STANDARD
K925066 · FOX
Arthrodyn, Inc.
General Hospital · 295d
Cleared Jul 28, 1993
SIGHT-PLUS ARTHROSCOPE
K925226 · HRX
American Medical Concepts, Inc.
Orthopedic · 285d
Cleared Jul 28, 1993
FUJINON VIDEO LAPAROSCOPE-ADDITIONAL INTENDED USE
K925599 · GCJ
Fujinon, Inc.
General & Plastic Surgery · 265d
Cleared Jul 28, 1993
ARCOM POLYETHYLENE ACETABULAR LINERS & COMPONENTS
K926107 · LPH
Biomet, Inc.
Orthopedic · 237d
Cleared Jul 28, 1993
ACCUTEX BETA-HCG TEST
K926112 · JHJ
J.S. Medical Assoc.
Chemistry · 237d
Cleared Jul 28, 1993
ECLIPSE 3200
K926210 · GEX
Cardiogenes
General & Plastic Surgery · 230d
Cleared Jul 28, 1993
ELECTROCAUTERY SHROUD
K930097 · GEI
I.C Medical, Inc.
General & Plastic Surgery · 201d
Cleared Jul 28, 1993
SPECULUM SMOKE EVACUATOR TUBING
K930098 · GEX
I.C Medical, Inc.
General & Plastic Surgery · 201d
Cleared Jul 28, 1993
LASER HANDPIECE SHROUD
K930099 · GEX
I.C Medical, Inc.
General & Plastic Surgery · 201d
Cleared Jul 28, 1993
ELECTRO FLOSS
K930178 · JET
Arizona Implant Dentistry
Dental · 196d
Cleared Jul 28, 1993
LAPAROSCOPIC LYMPHADENECTOMY
K930817 · GCJ
Fujinon, Inc.
General & Plastic Surgery · 161d
Cleared Jul 28, 1993
ACCULITE(TM) OTOPROBE
K930981 · GEX
Coherent Medical Group
General & Plastic Surgery · 153d
Cleared Jul 28, 1993
FUJINON VIDEO LAPAROSCOPE--THORACOSCOPY
K931223 · GCJ
Fujinon, Inc.
General & Plastic Surgery · 140d
Cleared Jul 28, 1993
TRI-POINT LIQUIMMUNE IMMUONASSAY CONTROL, L-1,2,3
K931366 · JJY
Medical Analysis Systems, Inc.
Immunology · 133d
Cleared Jul 28, 1993
GAMMACON IMAGE TRANSLATION SYSTEM
K931376 · LLZ
Numa Corp.
Radiology · 134d