FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
13753–13776 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 2022
MyoCycle MC-2 (Home / Home + / Pro / Pro +)
K213925 · GZI
Myolyn, LLC
Neurology · 130d
Cleared Apr 25, 2022
Disposable Surgical Face Mask (M01, M02)
K220512 · FXX
Fomed Industries, Inc.
General Hospital · 62d
Cleared Apr 25, 2022
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System
K221041 · PPN
Shockwave Medical, Inc.
Cardiovascular · 17d
Cleared Apr 24, 2022
IVX Fluid Transfer Set
K212530 · LHI
Omnicell, Inc.
General Hospital · 256d
Cleared Apr 24, 2022
Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves
K213775 · LYY
Avecena Gloves Sdn Bhd
General Hospital · 143d
Cleared Apr 23, 2022
TENS device-EmeTerm 2, Model: YF-ZTY-E2
K220503 · GZJ
Wat Medical Technology, Inc.
Neurology · 60d
Cleared Apr 22, 2022
CoNextions TR Tendon Repair System
K203855 · GAQ
Conextions Medical
General & Plastic Surgery · 477d
Cleared Apr 22, 2022
LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel
K211123 · FRO
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 372d
Cleared Apr 22, 2022
F&P 850 AirSpiral Adult NIV and NHF Circuit Kit
K212031 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 297d
Cleared Apr 22, 2022
Electric Scooter
K212090 · INI
Anhui Jbh Medical Apparatus Co., Ltd.
Physical Medicine · 290d
Cleared Apr 22, 2022
SONON Ultrasound Imaging System, Model: SONON 500L
K212400 · IYN
Healcerion Co., Ltd.
Radiology · 263d
Cleared Apr 22, 2022
RibFix Blu Thoracic Fixation System
K212608 · HRS
Biomet Microfixation
Orthopedic · 248d
Cleared Apr 22, 2022
Lorals
K212928 · MSC
Brazen Goods Inc. Dba Lorals
Obstetrics & Gynecology · 220d
Cleared Apr 22, 2022
MirrorMe3D Modeling System
K212981 · LLZ
Mirrorme3D, LLC
Radiology · 217d
Cleared Apr 22, 2022
ATUSA™ Automated 3D Breast Ultrasound System
K213620 · IYO
Isono Health, Inc.
Radiology · 157d
Cleared Apr 22, 2022
Promisemed Fine Biopsy Needle
K213683 · KNW
Promisemed Hangzhou Meditech Co., Ltd.
General & Plastic Surgery · 151d
Cleared Apr 22, 2022
ROSA® Knee System
K213708 · OLO
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 149d
Cleared Apr 22, 2022
PicoStar
K213889 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 130d
Cleared Apr 22, 2022
HealthOST
K213944 · JAK
Nanoxai , Ltd.
Radiology · 126d
Cleared Apr 22, 2022
HYBRID S70
K220574 · EHD
Digimed Co., Ltd.
Radiology · 53d
Cleared Apr 22, 2022
Avanos* CORTRAK* 2 Enteral Access System (EAS)
K220588 · KNT
Avanos Medical, Inc.
Gastroenterology & Urology · 52d
Cleared Apr 22, 2022
1 Series Phototherapy Equipment
K220840 · FTC
Daavlin Distributing Co.
General & Plastic Surgery · 30d
Cleared Apr 22, 2022
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688...
K220895 · GCJ
Stryker
General & Plastic Surgery · 25d
Cleared Apr 21, 2022
Waterlase iPLus
K210183 · GEX
Biolase, Inc.
General & Plastic Surgery · 451d