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
76585–76608 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2001
FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE
K013273 · DQA
Fukuda Denshi USA, Inc.
Anesthesiology · 80d
Cleared Dec 20, 2001
VENTLAB HYPERINFLATION BAG SYSTEM
K013308 · NHK
Ventlab Corp.
Anesthesiology · 77d
Cleared Dec 20, 2001
RT-PLUS KNEE ADDITIONAL COMPONENTS
K013340 · KRO
Plus Orthopedics
Orthopedic · 72d
Cleared Dec 20, 2001
BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
K013377 · LPL
Ocular Sciences Puerto Rico, Inc.
Ophthalmic · 69d
Cleared Dec 20, 2001
NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM
K013419 · LLZ
Nicolet Biomedical
Radiology · 66d
Cleared Dec 20, 2001
INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND
K013424 · HTY
Hand Innovations, Inc.
Orthopedic · 66d
Cleared Dec 20, 2001
FRIALIT-2 ESTHETICBASE ABUTMENT
K013438 · DZE
Friadent GmbH
Dental · 64d
Cleared Dec 20, 2001
GLUSITE, MODEL GLU002
K013446 · EMA
Glustitch, Inc.
Dental · 64d
Cleared Dec 20, 2001
TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING
K013475 · LPH
Howmedica Osteonics Corp.
Orthopedic · 62d
Cleared Dec 20, 2001
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K013512 · LPN
Ciba Vision Corporation
Ophthalmic · 59d
Cleared Dec 20, 2001
MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM)
K013901 · GEX
Cardiofocus, Inc.
General & Plastic Surgery · 24d
Cleared Dec 20, 2001
MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET
K013916 · BWC
Cook, Inc.
Anesthesiology · 23d
Cleared Dec 20, 2001
HAND-CARRIED ULTRASOUND SYSTEM
K014116 · IYN
Sonosite,Inc.
Radiology · 6d
Cleared Dec 19, 2001
MEDPOR COATED TEAR DRAIN
K012108 · OKS
Porex Surgical, Inc.
Ophthalmic · 166d
Cleared Dec 19, 2001
DIGICAP
K012199 · GAB
Humana USA, Inc.
General Hospital · 159d
Cleared Dec 19, 2001
ANISEIKONIA INSPECTOR
K013110 · HJT
Optical Diagnostics, Inc.
Ophthalmic · 161d
Cleared Dec 19, 2001
MICROGYN PLUS STIMULATION DEVICE
K013141 · KPI
Hollister, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 19, 2001
MULTITAK SUTURE SNAP SYSTEM
K013177 · GAM
Bonutti Research, Inc.
General & Plastic Surgery · 86d
Cleared Dec 19, 2001
SYNTHES LCP DISTAL TIBIA PLATES
K013248 · HRS
Synthes (Usa)
Orthopedic · 82d
Cleared Dec 19, 2001
BLUE LATEX EXAMINATION GLOVES, POWDER FREE
K013320 · LYY
Arista Latindo Industrial Ltd. P.T
General Hospital · 75d
Cleared Dec 19, 2001
GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE
K013346 · LYC
W.L. Gore & Associates, Inc.
Dental · 71d
Cleared Dec 19, 2001
MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM
K013449 · HSB
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 63d
Cleared Dec 19, 2001
AUROFLUID PLUS
K013505 · EJT
Metalor Technologies USA
Dental · 58d
Cleared Dec 19, 2001
PRE-LOADED ULTRAFIX RC
K013553 · MBI
Linvatec Corp.
Orthopedic · 55d