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
154417–154440 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 1984
OCUCARE ULTRASOUND TIP & FREEDOM PACK
K834543 · HQC
Intermedics Intraocular, Inc.
Ophthalmic · 99d
Cleared Mar 16, 1984
SURGICAL KNIFE
K834546 · HNN
Fine-Cut Diamond Instruments
Ophthalmic · 80d
Cleared Mar 16, 1984
COLTENE BRILLIANT
K840085 · EBF
Bauer, Cheng & Associates, Inc.
Dental · 66d
Cleared Mar 16, 1984
EYE SURGERY INSTRUMENT
K840101 · HOB
Truline Instruments, Inc.
Ophthalmic · 66d
Cleared Mar 16, 1984
CAMTEX 1000
K840134 · JAA
Digital Imaging Co. of America
Radiology · 72d
Cleared Mar 16, 1984
LINEAR ACCELERATOR MULTIPLE EXL 3-4-6
K840136 · IYE
Adac Laboratories
Radiology · 73d
Cleared Mar 16, 1984
DENTAL ULTRASONIC SCALER/ENDOSONIC
K840141 · ELC
CooperVision, Inc.
Dental · 71d
Cleared Mar 16, 1984
DIGITAL FLUOROGRAPHY X-RAY SYSTEM
K840191 · JAA
Adac Laboratories
Radiology · 58d
Cleared Mar 16, 1984
MOTOR TILTED EXAM. TABLE UV-56
K840226 · IXR
Medicor USA , Ltd.
Radiology · 57d
Cleared Mar 16, 1984
CEHPALOMETRIC HEAD POSITIONER
K840275 · EAH
Gary E. Hall, Dds
Radiology · 53d
Cleared Mar 16, 1984
URETHRAL CATH. TRAY W/BAG
K840292 · KNX
Corpak Co.
Gastroenterology & Urology · 52d
Cleared Mar 16, 1984
COLTENE ORALLOY MAGICAPS
K840297 · EJJ
Coltene, Inc.
Dental · 52d
Cleared Mar 16, 1984
CATEGORY 6 OPTHALMIC DEVICES
K840310 · HOB
Imm Enterprises , Ltd.
Ophthalmic · 52d
Cleared Mar 16, 1984
ENDODYNE DUAL
K840321 · LIH
Elmed, Inc.
Neurology · 51d
Cleared Mar 16, 1984
INLINE FOAM NOSE
K840398 · BYD
Mallinckrodt Critical Care
Anesthesiology · 46d
Cleared Mar 16, 1984
FOAM NOSE
K840399 · BYD
Mallinckrodt Critical Care
Anesthesiology · 46d
Cleared Mar 16, 1984
STERILIZED DISPOS. CYSTOTOME
K840442 · HMX
Microsurgical Technology, Inc.
Ophthalmic · 44d
Cleared Mar 16, 1984
NEONATE MASK FOR BABIES
K840444 · HOY
Richards Medical Co., Inc.
Ophthalmic · 44d
Cleared Mar 16, 1984
EYE SPEAR
K840471 · HOZ
Surgicot, Inc.
Ophthalmic · 42d
Cleared Mar 16, 1984
PORTABLE TRANSIT CHAIR
K840638 · INM
Poirier S.A.
Physical Medicine · 56d
Cleared Mar 16, 1984
ANTERIOR CAPSULECTOMY CYSTITOME
K840659 · HNY
Sharpoint, Inc.
Ophthalmic · 30d
Cleared Mar 16, 1984
POSTERIOR CAPSULOTOMY CYSTITOME
K840660 · HNY
Sharpoint, Inc.
Ophthalmic · 30d
Cleared Mar 16, 1984
UXM MODEL 8188
K840678 · IZX
Universal X-Ray
Radiology · 30d
Cleared Mar 16, 1984
POWERMAT VRP-1 X-RAY IMAGING
K840698 · IWZ
Powers Chemco, Inc.
Radiology · 29d