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
52153–52176 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 2009
OPTOMED SMARTSCOPE, MODEL M3-1 EY1
K092056 · HKI
Optomed OY
Ophthalmic · 86d
Cleared Oct 01, 2009
CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)
K092195 · NUV
Cutera, Inc.
General & Plastic Surgery · 72d
Cleared Oct 01, 2009
DYNESYS TOP-LOADING SPINAL SYSTEM
K092234 · NQP
Zimmer Spine, Inc.
Orthopedic · 70d
Cleared Oct 01, 2009
SEAMFREE
K092539 · EBF
Apex Dental Materials, Inc.
Dental · 43d
Cleared Oct 01, 2009
EVISION DATA MANAGEMENT SOFTWARE
K092678 · DQA
Nonin Medical, Inc.
Anesthesiology · 30d
Cleared Oct 01, 2009
GUARDIAN II HEMOSTASIS VALVE
K092711 · DTL
Zerusa Limited
Cardiovascular · 28d
Cleared Oct 01, 2009
IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT
K092867 · ELW
Kettenbach GmbH & Co. KG
Dental · 13d
Cleared Sep 30, 2009
PARCUS PPEK CF INTERFERENCE SCREW
K091093 · HWC
Parcus Medical, LLC
Orthopedic · 167d
Cleared Sep 30, 2009
PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264
K091094 · MBI
Parcus Medical, LLC
Orthopedic · 167d
Cleared Sep 30, 2009
POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER
K091962 · ODF
Lumenis, Inc.
Gastroenterology & Urology · 91d
Cleared Sep 30, 2009
CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE
K092003 · MNR
MyCardio, LLC
Anesthesiology · 90d
Cleared Sep 30, 2009
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF
K092161 · DXN
Health & Life Co., Ltd.
Cardiovascular · 76d
Cleared Sep 30, 2009
INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL...
K092666 · HCG
Boston Scientific Corp
Neurology · 30d
Cleared Sep 29, 2009
HS AMICA
K083157 · NEY
H.S Hospital Service S.P.A
General & Plastic Surgery · 340d
Cleared Sep 29, 2009
SYNERGY
K083378 · GWM
Innerspace, Inc.
Neurology · 319d
Cleared Sep 29, 2009
AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER...
K090117 · FMI
Autosafe-Reflex, Inc.
General Hospital · 251d
Cleared Sep 29, 2009
PERIMETER INTERBODY FUSION DEVICE
K090353 · MAX
Medtronic Sofamor Danek
Orthopedic · 230d
Cleared Sep 29, 2009
JOURNEY BCS KNEE SYSTEM
K091014 · JWH
Smith & Nephew, Inc.
Orthopedic · 173d
Cleared Sep 29, 2009
CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
K091637 · KNT
Corpak Medsystems
Gastroenterology & Urology · 117d
Cleared Sep 29, 2009
AADVA ZR COLORING LIQUID
K092020 · EIH
GC America, Inc.
Dental · 85d
Cleared Sep 29, 2009
GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4
K092278 · HIH
Gyrus Acmi, Inc.
Obstetrics & Gynecology · 63d
Cleared Sep 29, 2009
MODEL GDCH-2000
K092851 · EIA
Global Dental Direct, Inc.
Dental · 13d
Cleared Sep 28, 2009
MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE
K083840 · GCM
Msi Medserv International Deutschland...
Gastroenterology & Urology · 278d
Cleared Sep 28, 2009
KAINOS+
K090387 · MQV
Signus Medizintechnik GmbH
Orthopedic · 223d