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
42385–42408 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 31, 2012
RESPIRONICS SIMPLYCLEAR DEVICE
K122111 · SDT
Respironics, Inc.
Anesthesiology · 167d
Cleared Dec 31, 2012
LIPIVIEW OCULAR SURFACE INTERFEROMETER
K122481 · HKI
Tearscience, Inc.
Ophthalmic · 139d
Cleared Dec 28, 2012
NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO...
K121007 · FOZ
Delta Med Srl
General Hospital · 269d
Cleared Dec 28, 2012
ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL...
K121297 · LPH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 242d
Cleared Dec 28, 2012
OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB...
K121397 · KHE
SEKISUI Diagnostics, LLC
Hematology · 233d
Cleared Dec 28, 2012
LANSINOH POWERED ELECTRIC BREAST PUMP
K122474 · HGX
Lansinoh Laboratories Saglik...
Obstetrics & Gynecology · 136d
Cleared Dec 28, 2012
RAPID STRAND RX
K122764 · KXK
Medi-Physics, Inc.
Radiology · 109d
Cleared Dec 28, 2012
DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM
K123167 · KWQ
Medos International SARL
Orthopedic · 80d
Cleared Dec 28, 2012
ONQ RTS
K123357 · MUJ
Oncology Systems, Inc.
Radiology · 58d
Cleared Dec 27, 2012
QUICK SAMPLER HOLDER
K120490 · JKA
Nipro Medical Corporation
Chemistry · 314d
Cleared Dec 27, 2012
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE
K121549 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 216d
Cleared CT Dec 27, 2012
INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS
K121653 · JAD
Carl Zeiss Meditec, Inc.
Radiology · 205d
Cleared Dec 27, 2012
EZ-ASSIST-FILL
K121661 · PCM
Assist Fill, LLC
Anesthesiology · 205d
Cleared Dec 27, 2012
A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS)
K121693 · MAX
Sapphire Medical Group, Inc.
Orthopedic · 203d
Cleared Dec 27, 2012
XPERT CT/NG
K121710 · LSL
Cepheid
Microbiology · 199d
Cleared Dec 27, 2012
KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B
K122039 · EBG
Kettenbach GmbH & Co. KG
Dental · 169d
Cleared Dec 27, 2012
FLEXLITE CAMERA
K122134 · HRX
Spine View, Inc.
Orthopedic · 162d
Cleared Dec 27, 2012
PRESTIGE-MOBIE
K122749 · INI
Prestige Sporting Goods Co. , Ltd.
Physical Medicine · 111d
Cleared Dec 27, 2012
NESS L300 SYSTEM KIT, LEF MODEL LG3-5100
K122784 · GZI
Bioness, Inc.
Neurology · 107d
Cleared Dec 27, 2012
SYNGO SINGLE SOURCE DUAL ENGERY
K122909 · JAK
Siemens Medical Systems, Inc.
Radiology · 97d
Cleared Dec 27, 2012
VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T
K123091 · MOS
Imris, Inc.
Radiology · 86d
Cleared Dec 27, 2012
EVA SELECT DIGITAL DENTAL IMAGING SYSTEM
K123419 · MUH
Afp Imaging Corp.
Radiology · 51d
Cleared Dec 27, 2012
CLEARREAD +CONFIRM
K123526 · LLZ
Riverain Technologies
Radiology · 42d
Cleared Dec 27, 2012
FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)
K123591 · DRA
Medtronic Cryocath, LP
Cardiovascular · 36d