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
16417–16440 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 2021
Nam illumination probe with chopper
K202670 · MPA
Oculight , Ltd.
Ophthalmic · 340d
Cleared Aug 20, 2021
Prime and DYNASTY® Additive Manufacturing Shells
K202705 · OQG
Microport Orthopedics, Inc.
Orthopedic · 338d
Cleared Aug 20, 2021
Auxilock Titanium Interference Screw
K203029 · HWC
Auxein Medical Private Limited
Orthopedic · 322d
Cleared Aug 20, 2021
Otoplan
K203486 · QQE
Cascination AG
Ear, Nose, Throat · 266d
Cleared Aug 20, 2021
MOSS VRS Spinal System
K203607 · NKB
Biedermann Motech GmbH & Co. KG
Orthopedic · 253d
Cleared Aug 20, 2021
Medical Gloves
K203622 · LZA
Beijing Biosis Healing Biolog Ical...
General Hospital · 252d
Cleared Aug 20, 2021
Latex Examination Glove, Powder free with Protein Content Labeling Claim (50...
K203705 · LYY
Careplus (M) Sdn Bhd
General Hospital · 245d
Cleared Aug 20, 2021
GEM Premier 5000
K203790 · CHL
Instrumentation Laboratory CO
Chemistry · 235d
Cleared Aug 20, 2021
Inset Reverse Total Shoulder System
K210533 · PHX
Shoulder Innovations, Inc.
Orthopedic · 177d
Cleared Aug 20, 2021
IO Expandable Lumbar Interbody Fusion System
K210800 · MAX
MiRus, LLC
Orthopedic · 157d
Cleared Aug 20, 2021
Altus Spine Sochi OCT Spinal System
K210887 · NKG
Altus Partners, LLC
Orthopedic · 148d
Cleared Aug 20, 2021
Molekule Air Pro
K211194 · FRA
Molekule, Inc.
General Hospital · 121d
Cleared Aug 20, 2021
Exo Iris
K211527 · IYN
Exo Imaging, Inc.
Radiology · 95d
Cleared Aug 20, 2021
Wishbone HA
K211551 · NPM
Wishbone SA
Dental · 93d
Cleared Aug 20, 2021
Nitrile Exam Gloves, Powder Free, Blue
K211699 · LZA
Hengchang (Dongying) Medical...
General Hospital · 78d
Cleared Aug 20, 2021
Simplify Disc
K211757 · QLQ
Nuvasive, Inc.
Orthopedic · 74d
Cleared Aug 20, 2021
Ez3D-i/E3
K211791 · LLZ
Ewoosoft Co., Ltd.
Radiology · 71d
Cleared Aug 20, 2021
Discovery MI Gen2
K211846 · KPS
Ge Medical Systems, LLC
Radiology · 66d
Cleared Aug 20, 2021
BC Reflex Uni Knee System
K211895 · HSX
Bodycad Laboratories, Inc.
Orthopedic · 60d
Cleared Aug 20, 2021
IPS e.max One
K211916 · EIH
Ivoclar Vivadent, AG
Dental · 60d
Cleared Aug 20, 2021
Ethos Treatment Management, Ethos Treatment Planning
K212294 · IYE
Varian Medical Systems, Inc.
Radiology · 29d
Cleared Aug 20, 2021
Omni Foot and Ankle Plating System
K212297 · HRS
Extremity Medical, LLC
Orthopedic · 29d
Cleared Aug 19, 2021
SurgiLattice scaffold
K202425 · OOD
Tepha, Inc.
General & Plastic Surgery · 359d
Cleared Aug 19, 2021
Servator P SALF Solution with THAM
K202652 · KDN
S.A.L.F. Spa
Gastroenterology & Urology · 339d