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
21049–21072 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 2020
CoLink Plating System, Fracture and Correction System, CoLink Mini Plating...
K193543 · HRS
In2bones USA, LLC
Orthopedic · 28d
Cleared Jan 17, 2020
CustomizedBone Service
K193547 · GXN
Fin-Ceramica Faenza S.P.A.
Neurology · 28d
Cleared Jan 17, 2020
Dental Pain Eraser
K193570 · LWM
Synapse Dental
Dental · 25d
Cleared Jan 17, 2020
CareSens S Fit BT Blood Glucose Monitoring System
K193590 · NBW
I-Sens, Inc.
Chemistry · 25d
Cleared Jan 16, 2020
Maxxi Snore Sensor
K191095 · MNR
Neurovirtual USA, Inc.
Anesthesiology · 266d
Cleared Jan 16, 2020
Resectr Tissue Resection Device
K191538 · HIH
Boston Scientific Corporation
Obstetrics & Gynecology · 220d
Cleared Jan 16, 2020
Electric Breast Pump
K191802 · HGX
Ningbo Huiyoo Baby Products Co., Ltd.
Obstetrics & Gynecology · 197d
Cleared Jan 16, 2020
MobiliT Cup
K191831 · LZO
Corin U.S.A. Limited
Orthopedic · 191d
Cleared Jan 16, 2020
INNOVO
K192357 · QAJ
Atlantic Therapeutics, Ltd.
Gastroenterology & Urology · 140d
Cleared Jan 16, 2020
AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip
K192750 · MBI
Parcus Medical, LLC
Orthopedic · 108d
Cleared Jan 16, 2020
SherpaPak Lung Preservation System , SherpaPak Liver Transport System
K192869 · KDN
Pragonix Technologies
Gastroenterology & Urology · 101d
Cleared Jan 16, 2020
ALLthread Titanium Suture Anchor
K192942 · MBI
Biomet, Inc.
Orthopedic · 90d
Cleared Jan 16, 2020
Auto Positioning
K192956 · JAK
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 87d
Cleared Jan 16, 2020
GlideScope BFlex 3.8 Single-Use Bronchoscope
K193488 · EOQ
Verathon Medical (Canada) Ulc
Ear, Nose, Throat · 30d
Cleared Jan 16, 2020
Stellar M22 for Intense Pulsed Light (IPL) and Laser System
K193500 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 30d
Cleared Jan 16, 2020
Viveve 2.0 System
K193611 · GEI
Viveve Medical, Inc.
General & Plastic Surgery · 21d
Cleared Jan 15, 2020
ClenchGuard
K181005 · OBR
Boyd Research, Inc.
Dental · 639d
Cleared Jan 15, 2020
INTRAcel RF Microneedle System
K183284 · GEI
Jeisys Medical, Inc.
General & Plastic Surgery · 415d
Cleared Jan 15, 2020
UNO 30
K190028 · OMP
Genadyne Biotechnologies
General & Plastic Surgery · 373d
Cleared Jan 15, 2020
NEX-D2 Posterior Fixation System
K190981 · NKB
Next Orthosurgical
Orthopedic · 275d
Cleared Jan 15, 2020
ADAS 3D
K191125 · LLZ
Galgo Medical S.L
Radiology · 261d
Cleared Jan 15, 2020
VitalScan ANS
K191266 · JOM
Medeia, Inc.
Cardiovascular · 250d
Cleared Jan 15, 2020
All’InCath 035M PTA Balloon Dilatation Catheter
K191275 · LIT
Nexstep Medical
Cardiovascular · 247d
Cleared Jan 15, 2020
Eko Analysis Software
K192004 · MWI
Eko Devices, Inc.
Cardiovascular · 173d