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
43297–43320 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 2012
AIM
K121479 · IYO
Inneroptic Technology, Inc.
Radiology · 118d
Cleared Sep 13, 2012
JAZZ SYSTEM
K121541 · JDQ
Implanet, S.A.
Orthopedic · 112d
Cleared Sep 13, 2012
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS
K121774 · MCW
Boston Scientific Corp
Cardiovascular · 87d
Cleared Sep 13, 2012
GSI VIEWER WITH VUE OPTION
K121827 · JAK
GE Medical Systems SCS
Radiology · 84d
Cleared Sep 13, 2012
STREPTOCOCCUS APP. SEROLOGICAL REAGENTS
K122019 · OYZ
Meridian Bioscience, Inc.
Microbiology · 65d
Cleared Sep 13, 2012
DX-D FULL LEG FULL SPINE
K122119 · KPR
Afga Healthcare N.V.
Radiology · 58d
Cleared Sep 13, 2012
PATIENT POSITIONING SYSTEM
K122413 · JAI
Forte Automation Systems, Inc.
Radiology · 36d
Cleared Sep 13, 2012
VIAMO SSA-640A V4.0
K122491 · IYN
Toshibamedical Systems Corporation
Radiology · 29d
Cleared Sep 13, 2012
VELASHAPE
K122579 · NUV
Syneron Medical, Ltd.
General & Plastic Surgery · 21d
Cleared Sep 13, 2012
PRECISION ENDOSCOPIC INFRARED COAGULATOR
K122593 · FEH
Optim, LLC
Gastroenterology & Urology · 20d
Cleared Sep 12, 2012
NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES
K112693 · LYY
Sgmp Co., Ltd.
General Hospital · 363d
Cleared Sep 12, 2012
VITAL COUGH
K120277 · NHJ
Lung Assist, Inc.
Anesthesiology · 226d
Cleared Sep 12, 2012
PROTECTOR, INJECTOR, CONNECTOR
K120384 · LHI
Bd Medical-Medical Surgical Systems
General Hospital · 218d
Cleared Sep 12, 2012
STRYKER VIDEO URETEROSCOPE
K121112 · FGB
Stryker Endoscopy
Gastroenterology & Urology · 153d
Cleared Sep 12, 2012
ALCO-SCREEN 02
K121256 · DIC
Chematics, Inc.
Toxicology · 140d
Cleared Sep 12, 2012
AYCAN MOBILE
K122260 · LLZ
Aycan Digitalsysteme GmbH
Radiology · 47d
Cleared Sep 12, 2012
CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE
K122427 · LLZ
Carestream Dental, LLC
Radiology · 34d
Cleared Sep 12, 2012
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC LAVA ULTIMATE CAD/CAM RESTORATIVE...
K122569 · EBF
3M Company
Dental · 20d
Cleared Sep 11, 2012
EUROIMMUN ANTI-SLA/LP ELISA(LGG)
K112221 · NIY
Euroimmun US
Immunology · 406d
Cleared Sep 11, 2012
EUROIMMUN ANTI-LKM-1 ELISA(LGG)
K112223 · NBS
Euroimmun US
Immunology · 406d
Cleared Sep 11, 2012
POWDER FREE BLACK NITRILE EXAMINATION GLOVES
K113393 · LZA
Tg Medical Sdn. Bhd.
General Hospital · 299d
Cleared Sep 11, 2012
TESTOSTERONE TEST SYSTEM
K120009 · CDZ
Abbott Laboratories
Chemistry · 252d
Cleared Sep 11, 2012
INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS
K120012 · GCJ
Integra LifeSciences Corporation
General & Plastic Surgery · 252d
Cleared Sep 11, 2012
ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)
K120766 · FAJ
Prosurg, Inc.
Gastroenterology & Urology · 182d