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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
124417–124440 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 1990
PERSONAL 120/210 BASIC ELECTROCARDIOGRAPH
K902368 · DPS
Esaote Biomedica Spa
Cardiovascular · 105d
Cleared Sep 11, 1990
ADG BONE PLUG
K902615 · LZN
American Design Group, Inc.
Orthopedic · 90d
Cleared Sep 11, 1990
SL-SELF LOCKING TOTAL HIP-FEMORAL COMPONENT
K902621 · JDI
Lima Intl. Corp.
Orthopedic · 89d
Cleared Sep 11, 1990
MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE
K903647 · LDM
Millipore Corp.
Chemistry · 33d
Cleared Sep 10, 1990
MODIFIED LYOFOAM WOUND DRESSINGS
K895764 · KMF
Acme United Corp.
General & Plastic Surgery · 349d
Cleared Sep 10, 1990
TIPSTOP(TM)
K896068 · KGX
Gambro-Hospal, Inc.
General & Plastic Surgery · 326d
Cleared Sep 10, 1990
ENDOBRUSH(TM) DEVICE
K897070 · HFE
Intl. Cytobrush, Inc.
Obstetrics & Gynecology · 262d
Cleared Sep 10, 1990
NIDEK MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA
K900890 · GEX
Nidek, Inc.
General & Plastic Surgery · 195d
Cleared Sep 10, 1990
NIDEK, INC. MODEL ADC-8000 DERM
K900925 · GEX
Nidek, Inc.
General & Plastic Surgery · 195d
Cleared Sep 10, 1990
LASERCOMP MODEL STAR 10 FOR KNEE ARTHROSCOPY
K901127 · GEX
Lasercomp
General & Plastic Surgery · 182d
Cleared Sep 10, 1990
AEROMIST II NEBULIZER
K901315 · CAF
Inhalation Plastics
Anesthesiology · 173d
Cleared Sep 10, 1990
MODIFICATION TO API UNISCEPT 20GP
K901559 · LQL
Analytical Products, Inc.
Microbiology · 160d
Cleared Sep 10, 1990
RAD-X GLASSES
K902280 · HQY
Compudrug
Ophthalmic · 111d
Cleared Sep 10, 1990
CYTOSET(TM)
K902589 · HHT
Birchwood Laboratories, Inc.
Obstetrics & Gynecology · 90d
Cleared Sep 10, 1990
CYTETTE(TM) CYTOLOGY BRUSH
K902591 · HHT
Birchwood Laboratories, Inc.
Obstetrics & Gynecology · 90d
Cleared Sep 10, 1990
DIRECTIGEN FLU A
K902609 · GNT
Bd Becton Dickinson Vacutainer...
Microbiology · 90d
Cleared Sep 10, 1990
MICROSCOPE DRAPE
K902851 · HMW
Medical Technique Instruments, Inc.
General Hospital · 73d
Cleared Sep 10, 1990
CIBA CORNING ACS DIGOXIN IMMUNOASSAY
K902861 · DON
Ciba Corning Diagnostics Corp.
Chemistry · 74d
Cleared Sep 10, 1990
SURGICAL LIGHTING-CENTRA 450
K902864 · FSY
Sds Dental, Inc.
General & Plastic Surgery · 73d
Cleared Sep 10, 1990
BAUMER SURGICAL TABLE
K902865 · BWN
Sds Dental, Inc.
General & Plastic Surgery · 73d
Cleared Sep 10, 1990
CUSTOMED ARTHROSCOPY PACK
K902887 · LRO
Customed, Inc.
General & Plastic Surgery · 70d
Cleared Sep 10, 1990
CUSTOMED ORTHOPEDIC II
K902888 · LRO
Customed, Inc.
General & Plastic Surgery · 70d
Cleared Sep 10, 1990
CELL-DYN CALIBRATOR
K902892 · KRZ
Unipath , Ltd.
Hematology · 70d
Cleared Sep 10, 1990
GYREX 2T VERSION 2.1U.
K903028 · LNH
Elscint, Inc.
Radiology · 61d