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
59473–59496 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 2007
SBI DISTAL RADIUS VOLAR PLATING SYSTEM
K070793 · HRS
Small Bone Innovations, Inc.
Orthopedic · 69d
Cleared May 30, 2007
MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP
K070814 · FMF
Confluent Surgical,Inc
General Hospital · 65d
Cleared May 30, 2007
POWDER FREE NITRILE EXAMINATION GLOVES (BLUE, WIHTE)
K070862 · LZA
Purtech Cleanroom Products Co., Ltd.
General Hospital · 63d
Cleared May 30, 2007
DIRECT DIGITIZER, REGIUS MODEL 110
K071181 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 30d
Cleared May 30, 2007
MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
K071185 · GXZ
Ambu A/S
Neurology · 30d
Cleared May 30, 2007
VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS
K071193 · MQB
Vidar Systems Corp.
Radiology · 30d
Cleared May 30, 2007
ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13
K071235 · DZE
Zimmer Dental, Inc.
Dental · 27d
Cleared May 30, 2007
VITAL CONNECT 4.1
K071362 · LLZ
Vital Images, Inc.
Radiology · 15d
Cleared May 29, 2007
ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136
K062025 · OBW
Corgenix, Inc.
Hematology · 315d
Cleared May 29, 2007
AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES
K062823 · JAQ
Alpha-Omega Services, Inc.
Radiology · 251d
Cleared May 29, 2007
50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB
K070264 · FMF
Terumo Europe N.V.
General Hospital · 120d
Cleared May 29, 2007
NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP
K070416 · BYE
Neoforce Group, Inc.
Anesthesiology · 106d
Cleared May 29, 2007
EVICEL APPLICATION DEVICE
K070575 · FMF
Omrix Biopharmaceuticals , Ltd.
General Hospital · 90d
Cleared May 29, 2007
FLEX ARM RETRACTOR SYSTEM
K071338 · GZT
Koros USA, Inc.
Neurology · 15d
Cleared May 25, 2007
ANATOMICA POSTERIOR CERVICAL FIXATION SYSTEM
K061943 · KWP
Anatomica AB
Orthopedic · 319d
Cleared May 25, 2007
EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES
K062171 · GEI
Ortho Development Corp.
General & Plastic Surgery · 298d
Cleared May 25, 2007
RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20
K063661 · NLF
Renu Medical, Inc.
Anesthesiology · 168d
Cleared May 25, 2007
MASSTRAK IMMUNOSUPPRESSANTS KIT
K063868 · MLM
Waters Corporation
Toxicology · 147d
Cleared May 25, 2007
AUTO DETECT FOR TELAHEART DR200/E-A
K070014 · MWJ
North East Monitoring, Inc.
Cardiovascular · 142d
Cleared May 25, 2007
ASCENT DENTAL CLEANSER
K070070 · LBH
CAO Group, Inc.
Dental · 137d
Cleared May 25, 2007
MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM
K070239 · NBW
Exir Pharmaceutical Co.
Chemistry · 120d
Cleared May 25, 2007
REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR
K070327 · LRK
Sybron Dental Specialties, Inc.
Dental · 109d
Cleared May 25, 2007
DURAMAX REUSABLE OXIMETRY SENSOR
K070408 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 102d
Cleared May 25, 2007
SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD)
K070547 · FPA
Terumo Europe N.V.
General Hospital · 88d