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
14761–14784 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 03, 2022
Air Compression Leg Massager (model: FE-7204B)
K211850 · IRP
Xiamen Healthpal Electronic Co.,Ltd
Physical Medicine · 261d
Cleared Mar 03, 2022
MyndMove 2.0
K212149 · GZI
Myndtec, Inc.
Physical Medicine · 237d
Cleared Mar 03, 2022
Osteon Precision Milled Suprastructure
K212676 · NHA
Implant Solutions Pty Ltd (Osteon...
Dental · 191d
Cleared Mar 03, 2022
nordicDSC
K212720 · LLZ
Nordicneurolab AS
Radiology · 188d
Cleared Mar 03, 2022
easy Claire
K213285 · OHS
Y & J Bio Co., Ltd.
General & Plastic Surgery · 153d
Cleared Mar 03, 2022
Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed...
K213516 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 120d
Cleared Mar 03, 2022
Astroglide Sensual Strawberry Personal Lubricant
K213671 · NUC
Biofilm, Inc.
Obstetrics & Gynecology · 101d
Cleared Mar 03, 2022
IV Administration Set
K213778 · FPA
B.Braun Medical, Inc.
General Hospital · 90d