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
53593–53616 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 2009
NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K083156 · LZA
Giga-Drive Sdn, Bhd
General Hospital · 196d
Cleared May 08, 2009
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS
K083499 · OTP
Coloplast A/S
Obstetrics & Gynecology · 164d
Cleared May 08, 2009
HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED),...
K083729 · GGW
Aniara Diagnostica, LLC
Hematology · 143d
Cleared May 08, 2009
ADVIA CENTAUR TSH3-ULTRA METHOD
K083844 · JLW
Siemens Healthcare Diagnostics
Chemistry · 135d
Cleared May 08, 2009
KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT
K090078 · NXM
Iop, Inc.
Ophthalmic · 116d
Cleared May 08, 2009
REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM
K090243 · BZD
Respironics Inc., Sleep & Home...
Anesthesiology · 95d
Cleared May 08, 2009
ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE
K090338 · MSY
Reprocessing Products Corp
Gastroenterology & Urology · 87d
Cleared May 08, 2009
ZIO PATCH, MODEL Z100
K090363 · DSH
iRhythm Technologies, Inc.
Cardiovascular · 84d
Cleared May 08, 2009
BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION...
K090409 · MXJ
Bio-Rad Laboratories
Microbiology · 79d
Cleared May 08, 2009
VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED)
K090513 · LYZ
Shandong Huayue Glove Co., Ltd.
General Hospital · 71d
Cleared May 08, 2009
SYNGO RT THERAPIST CONNECT
K090683 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 53d
Cleared May 08, 2009
ORTHOLOC 2.0/2.4 PLATE SYSTEM
K090692 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 53d
Cleared May 08, 2009
FLEX-TENS
K090717 · GZJ
Emsi
Neurology · 51d
Cleared May 08, 2009
CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR...
K090864 · LFL
Integra Radionics, Inc.
General & Plastic Surgery · 39d
Cleared May 08, 2009
ACCUTORR V MONITOR, MODEL 0998-00-2000
K091068 · DXN
Datascope Corp., Patient Monitoring...
Cardiovascular · 24d
Cleared May 08, 2009
NUVASIVE LATERAL PLATE SYSTEM
K091071 · KWQ
Nuvasive, Inc.
Orthopedic · 24d
Cleared May 08, 2009
PELVIC FLOOR REPAIR SYSTEM
K091131 · OTP
Boston Scientific
Obstetrics & Gynecology · 18d
Cleared May 08, 2009
GRIND NO MORE VERSION 2 AND 3
K091175 · OBR
Ranir, LLC
Dental · 16d
Cleared May 08, 2009
MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM
K091257 · FCG
Medi-Globe Corporation
Gastroenterology & Urology · 9d
Cleared May 08, 2009
NEUROPET
K091269 · KPS
Photodetection Systems, Inc.
Radiology · 8d
Cleared May 07, 2009
SAFEFLO VENA CAVA FILTER
K081138 · DTK
Rmt Medical Technilogies, Inc.
Cardiovascular · 381d
Cleared May 07, 2009
CIRCULATOR BOOT
K082134 · DRN
Circulator Boot Corp.
Cardiovascular · 282d
Cleared May 07, 2009
INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT
K082497 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 251d
Cleared May 07, 2009
ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC
K082834 · GEI
Ellman Int'L, Inc.
General & Plastic Surgery · 223d