FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
77089–77112 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2001
NORIAN SRS BONE VOID FILLER
K011897 · MQV
Synthes (Usa)
Orthopedic · 185d
Cleared Dec 20, 2001
GELBISH VASCULAR DILATOR
K012256 · DRE
Vascumetrix, LLC
Cardiovascular · 155d
Cleared Dec 20, 2001
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM
K012323 · MNS
Respironics, Inc.
Anesthesiology · 150d
Cleared Dec 20, 2001
CSIST DICOM GATEWAY/IMAGE MANAGER
K012327 · LLZ
Csist
Radiology · 150d
Cleared Dec 20, 2001
GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES
K012660 · FET
Gimmi GmbH
Gastroenterology & Urology · 129d
Cleared Dec 20, 2001
SIGN IM NAIL
K013132 · HSB
Surgical Implant Generation Network...
Orthopedic · 92d
Cleared Dec 20, 2001
PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE...
K013172 · EZL
Porges S.A.
Gastroenterology & Urology · 87d
Cleared Dec 20, 2001
FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II
K013218 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 85d
Cleared Dec 20, 2001
EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT
K013226 · HGY
Evenflo Company, Inc.
Obstetrics & Gynecology · 84d
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