FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
13657–13680 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 08, 2022
EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)
K220374 · NKB
Medos International SARL
Orthopedic · 27d
Cleared Mar 07, 2022
BTL-785W
K211639 · GEI
BTL Industries, Inc.
General & Plastic Surgery · 284d
Cleared Mar 07, 2022
syngo.CT Applications
K220450 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 18d
Cleared Mar 07, 2022
SkinPen Precision System
K220506 · QAI
Crown Aesthetics
General & Plastic Surgery · 13d
Cleared Mar 04, 2022
InRoad® Dental Synthetic Bone Graft
K202675 · LYC
Osteogene Tech Corp
Dental · 535d
Cleared Mar 04, 2022
Disposable Automatically Retractable Insulin Safety Syringe
K210216 · MEG
Shantou Wealy Medical Instrument Co.,Ltd
General Hospital · 401d
Cleared Mar 04, 2022
Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use...
K210330 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 393d
Cleared Mar 04, 2022
Second Opinion
K210365 · MYN
Pearl, Inc.
Radiology · 389d
Cleared Mar 04, 2022
Medcare Powder-Free Blue Nitrile Patient Examination Gloves
K211808 · LZA
Dongguan Grinvald Technology Co., Ltd.
General Hospital · 266d
Cleared Mar 04, 2022
PolyLock Plating System
K211843 · HRS
Fusion Orthopedics
Orthopedic · 262d
Cleared Mar 04, 2022
Patient Information Center iX
K211900 · MHX
Philips Medizin Systeme B?blingen GmbH
Cardiovascular · 256d
Cleared Mar 04, 2022
KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat
K211919 · KNN
Kinetic Innovative Seating System, LLC
Physical Medicine · 256d
Cleared Mar 04, 2022
Surgical Trays
K212281 · KCT
Dentsply Sirona, Inc.
General Hospital · 226d
Cleared Mar 04, 2022
Exactech® Equinoxe® Laser Cage Glenoid
K212356 · KWS
Exactech, Inc.
Orthopedic · 218d
Cleared Mar 04, 2022
BTL-995-rTMS
K212723 · OBP
BTL Industries, Inc.
Neurology · 189d
Cleared Mar 04, 2022
Skanmobile, Skanmobile-Dr
K212940 · IZL
Skanray Technologies Limited
Radiology · 170d
Cleared Mar 04, 2022
Surgical Mask
K213358 · FXX
Shenzhen Safesecure Medical Infection...
General Hospital · 143d
Cleared Mar 04, 2022
Surgical Gown
K213703 · FYA
Wujiang Tutaike Textiles & Finishing...
General Hospital · 100d
Cleared Mar 04, 2022
Flexible Block
K213994 · EBI
Shandong Huge Dental Material...
Dental · 73d
Cleared Mar 04, 2022
TE Air Diagnostic Ultrasound System
K220051 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 57d
Cleared Mar 04, 2022
geko W-3
K220327 · IPF
Firstkind Limited
Physical Medicine · 28d
Cleared Mar 03, 2022
OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with...
K211658 · MOS
Noras Mri Products GmbH
Radiology · 279d
Cleared Mar 03, 2022
Hemoclip
K211787 · PKL
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 267d
Cleared Mar 03, 2022
Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal...
K211811 · GDW
Wuxi Beien Surgery Device Co., Ltd.
General & Plastic Surgery · 265d