FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
24265–24288 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 2018
Elevo® Kit Snoring Intervention Device
K181107 · LRK
Zelegent, Inc.
Ear, Nose, Throat · 224d
Cleared Dec 06, 2018
DePuy Synthes T-PAL Spacer System
K181231 · MAX
Depuy Synthes Spine
Orthopedic · 211d
Cleared Dec 06, 2018
PATRIOT® Lumbar Spacers, SUSTAIN® Spacers
K181357 · MAX
Globus Medical, Inc.
Orthopedic · 198d
Cleared CT Dec 06, 2018
Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic...
K181529 · LIT
Contego Medical, LLC
Cardiovascular · 178d
Cleared Dec 06, 2018
Vivid iq
K181727 · IYN
GE Medical Systems Ultrasound and...
Radiology · 160d
Cleared Dec 06, 2018
MagnetOs Putty
K181958 · MQV
Kuros Biosciences B.V
Orthopedic · 136d
Cleared Dec 06, 2018
Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths
K182006 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 132d
Cleared Dec 06, 2018
Simplicit90Y
K182016 · LLZ
Mirada Medical, Ltd.
Radiology · 132d
Cleared CT Dec 06, 2018
FFRct
K182035 · PJA
HeartFlow, Inc.
Cardiovascular · 129d
Cleared Dec 06, 2018
EVOLUTION Stemmed CS Femur
K182125 · JWH
Microport Orthopedics, Inc.
Orthopedic · 122d
Cleared Dec 06, 2018
PowerLook Tomo Detection V2 Software
K182373 · QDQ
Icad, Inc.
Radiology · 97d
Cleared Dec 06, 2018
Synthetic Polyisoprene Lubricated Male Condom - 5 senses
K182438 · MOL
Sxwell USA, LLC
Obstetrics & Gynecology · 90d
Cleared Dec 06, 2018
KerraContact Ag Perf Advanced Perforated Silver Wound Dressing
K182680 · FRO
Exciton Technologies, Inc.
General & Plastic Surgery · 71d
Cleared Dec 06, 2018
IntelliSpace Radiology
K182926 · LLZ
Philips Healthcare Informatics, Inc.
Radiology · 45d
Cleared Dec 06, 2018
Zenition 70
K183040 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 35d
Cleared Dec 06, 2018
Senhance Surgical System
K183098 · NAY
Transenterix, Inc.
General & Plastic Surgery · 29d
Cleared Dec 06, 2018
Unity Network ID
K183116 · MWI
Ge Healthcare
Cardiovascular · 27d
Cleared CT Dec 04, 2018
AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer...
K180615 · LKN
Fresenius Kabi USA,Llc
Gastroenterology & Urology · 271d
Cleared Dec 04, 2018
Spartan eCoil System
K180653 · HCG
Spartan Micro, Inc.
Neurology · 266d
Cleared Dec 04, 2018
HS50 / HS60 Diagnostic Ultrasound System
K181336 · IYN
Samsung Medison Co., Ltd.
Radiology · 197d
Cleared Dec 04, 2018
CAAS MR Solutions
K181825 · LLZ
Pie Medical Imaging BV
Radiology · 148d
Cleared Dec 04, 2018
Endoform Reconstructive Template - Non Absorbable
K181935 · FTL
Aroa Biosurgery , Ltd.
General & Plastic Surgery · 138d
Cleared Dec 04, 2018
MectaLIF Posterior Extension
K181970 · MAX
Medacta International S.A.
Orthopedic · 133d
Cleared Dec 04, 2018
Elekta Unity
K182076 · IYE
Elekta Limited
Radiology · 125d