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
45649–45672 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 2011
INTEGRITY(TM)
K112613 · IYE
Elekta Limited
Radiology · 100d
Cleared Dec 16, 2011
AIRLIGHT DENTAL HANDPIECE
K112623 · EFB
Beyes Dental Canada, Inc.
Dental · 99d
Cleared Dec 16, 2011
GE DATEX-OHMEDA AVANCE
K112722 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 88d
Cleared Dec 16, 2011
ER35 ERO-SCAN PRO HEARING TEST SYSTEM
K112733 · EWO
Etymotic Research, Inc.
Ear, Nose, Throat · 87d
Cleared Dec 16, 2011
SAME/VARIOUS DISTRIBUTORS/WE MAY PRIVATE LABEL
K112743 · LYZ
Clean Medical Manfacturing Co;Ltd
General Hospital · 86d
Cleared Dec 16, 2011
TINNITUS THERAPY SYSTEM ANM T30 CR
K112752 · KLW
Anm Adaptive Neuromodulation GmbH
Ear, Nose, Throat · 86d
Cleared Dec 16, 2011
NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER
K112770 · NQQ
Ninepoint Medical, Inc.
General & Plastic Surgery · 84d
Cleared Dec 16, 2011
RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW
K112819 · HRS
Xiamen Double Engline Medical...
Orthopedic · 79d
Cleared Dec 16, 2011
EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400
K112869 · EFB
Beyes Dental Canada, Inc.
Dental · 77d
Cleared Dec 16, 2011
SPOTLIGHT ACCESS SYSTEM
K112913 · GZT
Johnson & Johnson
Neurology · 74d
Cleared Dec 16, 2011
TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM
K112987 · GEX
Biolitec Medical Devices, Inc.
General & Plastic Surgery · 71d
Cleared Dec 16, 2011
REMSTAR AUTO A-FLEX HT
K113068 · BZD
Respironics, Inc.
Anesthesiology · 60d
Cleared Dec 16, 2011
COMPREHENSIVE REVERSE SHOULDER
K113121 · PHX
Biomet Manufacturing, Inc.
Orthopedic · 56d
Cleared Dec 16, 2011
PATIENT EXAMINATION GLOVE
K113193 · LYZ
Suqian Ruijang Medical Supplies Co.,...
General Hospital · 46d
Cleared Dec 16, 2011
INSTINCT JAVA SYSTEM
K113270 · NKB
Zimmer Spine
Orthopedic · 42d
Cleared Dec 16, 2011
FIXATE TISSUE BAND
K113400 · GZB
Anulex Technologies, Inc.
General & Plastic Surgery · 29d
Cleared Dec 16, 2011
HYDROCOIL EMBOLIC SYSTEM (HES)
K113457 · HCG
MicroVention, Inc.
Neurology · 24d
Cleared Dec 16, 2011
ANSPACH DISSECTION TOOLS
K113476 · HBE
The Anspach Effort, Inc.
Neurology · 24d
Cleared Dec 16, 2011
CLEARSTART SVM SYSTEM
K113541 · LLZ
Intio, Inc.
Radiology · 15d
Cleared Dec 16, 2011
ONDEMAND3D
K113543 · LLZ
Cybermed, Inc.
Radiology · 15d
Cleared Dec 16, 2011
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM
K113647 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 4d
Cleared Dec 15, 2011
INTRAORAL BELSENSOR GOLD
K102456 · MUH
Takara Belmont USA, Inc.
Radiology · 475d
Cleared Dec 15, 2011
BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA...
K102898 · LKF
Panpac Medical Corporation
Obstetrics & Gynecology · 441d
Cleared Dec 15, 2011
LANCER PEDICLE SCREW SYSTEM
K110633 · MNH
Spinal Solutions, LLC
Orthopedic · 286d