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
115777–115800 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 06, 1992
USP TYPE VII GAUZE SPONGES
K923378 · NAB
E.W.A., Ltd.
General & Plastic Surgery · 89d
Cleared Oct 06, 1992
DERMCO A-I
K923400 · KGX
Dermaco, Inc.
General & Plastic Surgery · 88d
Cleared Oct 06, 1992
SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA
K923480 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 83d
Cleared Oct 06, 1992
LIQUICHEK RHEUMATOID FACTOR CONTROL
K923578 · DHR
Bio-Rad
Immunology · 78d
Cleared Oct 06, 1992
METAFIL
K923867 · EBF
Parkell
Dental · 64d
Cleared Oct 06, 1992
SILIMAT PLUS
K923974 · EFD
Ivoclar North America, Inc.
Dental · 60d
Cleared Oct 06, 1992
OPTISOL-GS CORNEAL STORAGE MEDIA
K924165 · LYX
Chiron Intraoptics
Ophthalmic · 48d
Cleared Oct 05, 1992
CORDGUARD BLOOD COLLECTION DEVICE
K912419 · HFW
O.B. Tech., Inc.
Obstetrics & Gynecology · 493d
Cleared Oct 05, 1992
SALMONELLA O GROUPING ANTISERA SET
K912791 · GRM
S.M.I. Medical, Inc.
Microbiology · 468d
Cleared Oct 05, 1992
PRIME CADI-120
K914148 · MEB
Prime Medical Products, Inc.
General Hospital · 385d
Cleared Oct 05, 1992
A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT
K914193 · GEI
Alto Development Corp.
General & Plastic Surgery · 383d
Cleared Oct 05, 1992
TECNOL INFECTION CONTROL MASK
K920203 · FXX
Tecnol Medical Products, Inc.
General Hospital · 263d
Cleared Oct 05, 1992
OTOVENT
K920840 · MJV
Abigo Medical AB
Ear, Nose, Throat · 224d
Cleared Oct 05, 1992
PX-100 PORTABLE X-RAY GENERATOR
K921116 · IZL
Acoma Medical Imaging, Inc.
Radiology · 210d
Cleared Oct 05, 1992
MRX-700
K921129 · ITY
Mrx-Ray Tube Corp.
Radiology · 209d
Cleared Oct 05, 1992
DDV LIGATOR
K921304 · KOA
North American Medical, Inc.
Gastroenterology & Urology · 208d
Cleared Oct 05, 1992
ULTRA PCI
K921426 · IYO
Advanced Medical Products, Inc.
Radiology · 195d
Cleared Oct 05, 1992
DRESSING CHANGE TRAY DECUBITUS ULCER/STERILE-DISP
K921490 · FRG
Trinity Laboratories, Inc.
General Hospital · 189d
Cleared Oct 05, 1992
PROPPER SUPER SERACULT(R)
K921798 · KHE
Propper Mfg. Co., Inc.
Hematology · 174d
Cleared Oct 05, 1992
NEEDLE TECHNOLOGIES SEED IMPLANT NEEDLE
K921886 · IWJ
Needle Technologies, Inc.
Radiology · 167d
Cleared Oct 05, 1992
ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT
K922376 · CGJ
Icn Biomedicals, Inc.
Chemistry · 138d
Cleared Oct 05, 1992
IMMUCHEM PRL-MW ELISA
K922715 · CFT
Icn Biomedicals, Inc.
Chemistry · 122d
Cleared Oct 05, 1992
TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL
K922722 · DCK
Simplicity Diagnostics, Inc.
Immunology · 122d
Cleared Oct 05, 1992
TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL
K922725 · DHR
Simplicity Diagnostics, Inc.
Immunology · 122d