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
47137–47160 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 2011
CONSENSUS KNEE SYSTEM
K110950 · MBH
Consensus Orthopedics, Inc.
Orthopedic · 84d
Cleared Jun 27, 2011
PROFLU+ ASSAY
K110968 · OCC
Gen-Probe Prodesse, Inc.
Microbiology · 82d
Cleared Jun 27, 2011
APEX ARC HIP STEM
K111193 · LZO
Omni Life Science, Inc.
Orthopedic · 60d
Cleared Jun 24, 2011
BIOPSY HANDY, MRI BIOPSY HANDY
K102771 · KNW
Somatex Medical Technologies GmbH
Gastroenterology & Urology · 273d
Cleared Jun 24, 2011
CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING
K103520 · KRH
Edwards Lifesciences, LLC
Cardiovascular · 206d
Cleared Jun 24, 2011
INOMAX DSIR (DELIVERY SYSTEM)
K110344 · MRN
Ino Therapeutics
Anesthesiology · 140d
Cleared Jun 24, 2011
SUREFIRE INFUSION CATHETER SYSTEM
K110459 · DQO
Surefire Medical, Inc.
Cardiovascular · 127d
Cleared Jun 24, 2011
IBAG
K110518 · KNX
Future Path Medical, LLC
Gastroenterology & Urology · 121d
Cleared Jun 24, 2011
SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK)
K110545 · MBI
Smith & Nephew, Inc.
Orthopedic · 119d
Cleared Jun 24, 2011
VIBERECT PENILE VIBRATORY STIMULATION DEVICE
K110566 · KXQ
Reflexonic, LLC
Obstetrics & Gynecology · 116d
Cleared Jun 24, 2011
EPIDUCER LEAD DELIVERY SYSTEM
K110609 · LHG
St Jude Medical
Neurology · 113d
Cleared Jun 24, 2011
F10
K110630 · KNG
Mediana Co., Ltd.
Obstetrics & Gynecology · 113d
Cleared Jun 24, 2011
MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT
K110684 · GXN
Vanduzen Dba Medcad
Neurology · 105d
Cleared Jun 24, 2011
SENSI
K110704 · DQD
Diacoustic Medical Devices (Pty) , Ltd.
Cardiovascular · 102d
Cleared Jun 24, 2011
MONACO RTP SYSTEM
K110730 · MUJ
Computerized Medical Systems, Inc.
Radiology · 100d
Cleared Jun 24, 2011
DISPOSABLE THYROID COLLAR
K110900 · KPY
Bloxr Corporation
Radiology · 85d
Cleared Jun 24, 2011
MERIT MEDICAL 20 ML SYRINGE
K111091 · FMF
Merit Medical Systems, Inc.
General Hospital · 66d
Cleared Jun 24, 2011
VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE...
K111096 · DSH
Vasomedical, Inc.
Cardiovascular · 65d
Cleared Jun 24, 2011
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG...
K111133 · LYY
Ssc Surat Thani
General Hospital · 63d
Cleared Jun 24, 2011
SUPRIS RETROPUBIC SLING SYSTEM
K111233 · OTN
Coloplast A/S
Gastroenterology & Urology · 53d
Cleared Jun 24, 2011
CX50 DIAGNOSTIC ULTRASOUND SYSTEM
K111513 · IYN
Philips Ultrasound, Inc.
Radiology · 23d
Cleared Jun 24, 2011
IMPAX VOLUME VIEWING
K111638 · LLZ
Agfa Healthcare N.V.
Radiology · 11d
Cleared Jun 23, 2011
AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5
K100716 · GGN
Aalto Scientific, Ltd.
Hematology · 468d
Cleared Jun 23, 2011
WART FREEZE
K101049 · GEH
Koninklijke Utermohlen NV
General & Plastic Surgery · 435d