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
19969–19992 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 2020
Frozen N
K193665 · GEH
Yozma Bmtech Co., Ltd.
General & Plastic Surgery · 149d
Cleared May 28, 2020
PicoSecond Nd: YAG Laser System
K200116 · GEX
Shanghai Apolo Medical Technology...
General & Plastic Surgery · 128d
Cleared May 28, 2020
Meridian Anterior Plate System, Regatta Lateral Plate System
K200885 · KWQ
SeaSpine Orthopedics Corporation
Orthopedic · 56d
Cleared May 28, 2020
DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic...
K200979 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 45d
Cleared May 28, 2020
firefly T-2
K201131 · NGX
Firstkind Limited
Physical Medicine · 30d
Cleared May 27, 2020
Phacoemulsification Needle (Tip) and Irrigation Sleeve
K192418 · HQC
Raico, LLC
Ophthalmic · 266d
Cleared May 27, 2020
Joline Kyphoplasty System Allevo
K192449 · NDN
Joline GmbH & Co. KG
Orthopedic · 264d
Cleared May 27, 2020
TRV
K192652 · LXV
Interacoustics A/S
Ear, Nose, Throat · 246d
Cleared May 27, 2020
Stimuplex Onvision System
K192914 · BSP
Philips Medical Systems Nederland B.V.
Anesthesiology · 225d
Cleared May 27, 2020
Restoration® Modular Hip System
K193233 · LPH
Howmedica Osteonics Corp. (Aka...
Orthopedic · 184d
Cleared May 27, 2020
Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse
K193336 · OLR
Synedgen, Inc.
General & Plastic Surgery · 177d
Cleared May 27, 2020
Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne...
K200253 · GEI
Ethicon Endo-Surgery
General & Plastic Surgery · 114d
Cleared May 27, 2020
Medical Diode Laser Hair Removal System
K200525 · GEX
Weifang Mingliang Electronics Co., Ltd.
General & Plastic Surgery · 86d
Cleared May 27, 2020
Guardian Needle Electrode
K200984 · GXZ
Rhythmlink International, LLC
Neurology · 43d
Cleared May 27, 2020
AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP
K201112 · DSP
Arrow International, Inc.
Cardiovascular · 30d
Cleared May 27, 2020
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
K201120 · NFT
Safecare Biotech (Hangzhou) Co., Ltd.
Toxicology · 30d
Cleared May 26, 2020
High-speed air turbine handpiece / Low-speed air turbine handpiece
K181691 · EFB
Foshan Wenjian Medical Instrument...
Dental · 699d
Cleared May 26, 2020
DiaPlus
K192392 · KLE
DiaDent Group International
Dental · 266d
Cleared May 26, 2020
Aqua Naina Sterile Saline Solution
K193441 · LPN
Chemtex USA, Inc.
Ophthalmic · 167d
Cleared CT May 26, 2020
The iNAP One Sleep Therapy System
K193460 · OZR
Somnice, Inc.
Anesthesiology · 162d
Cleared May 26, 2020
ReWalk P6.0
K200032 · PHL
Re Walk Robotics , Ltd.
Neurology · 140d
Cleared May 26, 2020
NPseal
K200305 · OKO
Guard Medical, Inc.
General & Plastic Surgery · 110d
Cleared May 26, 2020
UNIEXPERT 2 PLUS
K200944 · KPR
Adani
Radiology · 48d
Cleared May 26, 2020
Maximus System
K200988 · NHJ
Hill-Rom Services Pte, Ltd.
Anesthesiology · 41d