Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
64441–64464 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 2005
KOWA GENESIS-D HAND-HELD RETINAL CAMERA
K050271 · HKI
Kowa Co. , Ltd.
Ophthalmic · 272d
Cleared Nov 03, 2005
ECLIPSE TREATMENT PLANNING SYSTEM
K050296 · MUJ
Varian Medical Systems
Radiology · 269d
Cleared Nov 03, 2005
GENEROS 80, GENEROS 60
K051914 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 112d
Cleared Nov 03, 2005
REGIUS MODEL 170 DIRECT DIGITIZER
K051998 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 101d
Cleared Nov 03, 2005
MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190
K052095 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 101d
Cleared Nov 03, 2005
ASCENSION MUH
K052137 · KXE
Ascension Orthopedics, Inc.
Orthopedic · 90d
Cleared Nov 03, 2005
PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS
K052435 · KNW
Pneumrx, Inc.
Gastroenterology & Urology · 58d
Cleared Nov 03, 2005
NOVABONE-BIOACTIVE SYNTHETIC GRAFT
K052494 · MQV
Novabone Products, LLC
Orthopedic · 52d
Cleared Nov 03, 2005
KIMBA SPINAL IMPLANT
K052533 · MQP
Signus Medizintechnik GmbH
Orthopedic · 49d
Cleared Nov 03, 2005
MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM
K052541 · KPR
Avant Medical Systems
Radiology · 49d
Cleared Nov 03, 2005
MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE
K052704 · MOS
Invivo Corp.
Radiology · 36d
Cleared Nov 03, 2005
ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT
K052736 · HTY
Arthrex, Inc.
Orthopedic · 34d
Cleared Nov 02, 2005
ABSOLUTE AMERICA
K050571 · EIA
Eurodent S.P.A.
Dental · 243d
Cleared Nov 02, 2005
Y2K2 ENTERNAL TUBE FLUID FILTER
K051206 · KNT
Moss Medical Products
Gastroenterology & Urology · 175d
Cleared Nov 02, 2005
ASAHI ANGIOGRAPHIC CATHETER
K051561 · DQO
Asahi Intecc Co., Ltd.
Cardiovascular · 142d
Cleared Nov 02, 2005
DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS
K051799 · DXT
Coeur, Inc.
Cardiovascular · 120d
Cleared Nov 02, 2005
EZ-MIO MANUAL DRIVER
K052195 · FMI
Vidacare Corporation
General Hospital · 83d
Cleared Nov 02, 2005
NAVIGATION SW HIP 3.1 ON CI
K052213 · HAW
Brainlab AG
Neurology · 79d
Cleared Nov 02, 2005
MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
K052253 · KPO
Gambro Renal Products
Gastroenterology & Urology · 76d
Cleared Nov 02, 2005
VISUCAM PRO NM
K052268 · HKI
Carl Zeiss Meditec, AG
Ophthalmic · 75d
Cleared Nov 02, 2005
TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND...
K052507 · HQD
The Lagado Corp.
Ophthalmic · 50d
Cleared Nov 02, 2005
LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AND OTHERS
K052722 · FPA
Hospira, Inc.
General Hospital · 34d
Cleared Nov 02, 2005
INTELLIVUE PATIENT MONITORS WITH RELEASE C.02, MODELS MP20, MP30, MP40, MP50,...
K052801 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 30d
Cleared Nov 02, 2005
SAUFLON FLAT COLOURED LENS CASE
K052809 · LRX
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 29d