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

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176,076 results
77689–77712 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 2001
MODIFICATION TO MAS CARDIOLMMUNE TL
K013995 · JJY
Medical Analysis Systems, Inc.
Chemistry · 17d
Cleared Dec 21, 2001
ENTEGRA PE PERSONAL DIGITAL ASSISTANT
K014058 · LLZ
General Electric Medical Systems
Radiology · 11d
Cleared Dec 21, 2001
BIOSCANNER PLUS
K014099 · NBW
Polymer Technology Systems, Inc.
Chemistry · 8d
Cleared Dec 20, 2001
SAUFLON MULTI LENS CARE SYSTEM
K010559 · LPN
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 297d
Cleared Dec 20, 2001
OXYLOG 1000, MODEL 2M86840
K010793 · CBK
Drager Medizintechnik GmbH
Anesthesiology · 279d
Cleared Dec 20, 2001
LORENZ LACTOSORB PANELS AND FASTENERS
K011139 · HRS
Biomet, Inc.
Orthopedic · 251d
Cleared Dec 20, 2001
FILTERFLO H
K011212 · CAH
Arc Medical, Inc.
General Hospital · 244d
Cleared Dec 20, 2001
3D LINE STEROTACTIC HARDWARE ACCESSORIES
K011255 · HAW
3D Line USA, Inc.
Neurology · 240d
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