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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
51313–51336 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 2010
BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706
K093972 · JKA
Becton, Dickinson & CO
Hematology · 28d
Cleared Jan 20, 2010
PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX
K082805 · FAD
Q Urological Corporation
Gastroenterology & Urology · 483d
Cleared Jan 20, 2010
WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX)
K092110 · HSB
Sonoma Orthopedic Products, Inc.
Orthopedic · 190d
Cleared Jan 20, 2010
THE PICC WAND PEELABLE SAFETY INTRODUCER
K093022 · DYB
Access Scientific, Inc.
Cardiovascular · 113d
Cleared Jan 20, 2010
FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000
K093065 · OPP
Calibra Medical, Inc.
General Hospital · 112d
Cleared Jan 20, 2010
QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000)
K093172 · DPS
Dynacardia, Inc.
Cardiovascular · 104d
Cleared Jan 20, 2010
CELOX PRO, CELOX PRO OTC, CELOX HEMOSTATIC GRANULES, CELOX PRO HEMOSTATIC...
K093593 · QSY
Medtrade Products Limited
General & Plastic Surgery · 62d
Cleared Jan 19, 2010
EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM
K091765 · NBW
Visgeneer, Inc.
Chemistry · 216d
Cleared Jan 19, 2010
BLADE ANTERIOR CERVICAL PLATE SYSTEM
K091936 · KWQ
Nexxt Medical, Inc.
Orthopedic · 203d
Cleared Jan 19, 2010
C. ALBICANS PNA FISH
K092655 · NZS
Advandx, Inc.
Microbiology · 144d
Cleared Jan 19, 2010
SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061
K092754 · HWC
Small Bone Innovations, Inc.
Orthopedic · 132d
Cleared Jan 19, 2010
IMMUNOCAP RAPID READER, MODEL 12-3600-10
K092978 · DHB
Phadia US, Inc.
Immunology · 113d
Cleared Jan 19, 2010
LIFE SPINE LUMBAR PLATE SYSTEM
K093200 · KWQ
Life Spine
Orthopedic · 102d
Cleared Jan 19, 2010
KEELER APPLANATION TONOMETER
K093445 · HKY
Keeler, Ltd.
Ophthalmic · 90d
Cleared Jan 19, 2010
POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE...
K093500 · LZC
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 68d
Cleared Jan 19, 2010
NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/...
K093693 · MOS
Noras Mri Products GmbH
Radiology · 50d
Cleared Jan 19, 2010
3DI
K093703 · LLZ
Shina Systems , Ltd.
Radiology · 49d
Cleared Jan 19, 2010
ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM
K093713 · ITX
Civco Medical Instruments
Radiology · 49d
Cleared Jan 19, 2010
ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM
K093849 · IYN
Medison Co., Ltd.
Radiology · 34d
Cleared Jan 19, 2010
CEROX MODEL 3210
K093923 · MUD
Or-Nim Medical , Ltd.
Cardiovascular · 28d
Cleared Jan 15, 2010
PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM
K091052 · DCN
Abaxis, Inc.
Immunology · 277d
Cleared Jan 15, 2010
ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS
K091259 · GEI
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 261d
Cleared Jan 15, 2010
MODERN MEDICAL RESECTOSCOPE ELECTRODES
K091511 · FAS
Modern Medical Equipment Mfg., Ltd.
Gastroenterology & Urology · 238d
Cleared Jan 15, 2010
NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS...
K091547 · NBW
Nova Biomedical Corp.
Chemistry · 233d