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
12649–12672 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 29, 2022
K-SHIELD Zen
K220799 · JKA
Sb-Kawasumi Laboratories, Inc.
General Hospital · 164d
Cleared Aug 29, 2022
Viz RV/LV
K221100 · QIH
Viz. Ai, Inc.
Radiology · 137d
Cleared Aug 29, 2022
Non-Mydriatic Retinal Camera NW500
K221111 · HKI
Topcon Corporation
Ophthalmic · 136d
Cleared Aug 29, 2022
OLIZ LTB-1000A
K221189 · ILY
Ltbio Co., Ltd.
Physical Medicine · 126d
Cleared Aug 29, 2022
TCL3 Motion Tracking System
K221785 · LNH
Tracinnovations A/S
Radiology · 69d
Cleared Aug 29, 2022
Rusch Intermittent Urethral Catheters
K222279 · EZC
Teleflex Medical
Gastroenterology & Urology · 31d
Cleared Aug 29, 2022
Salvo® Spine System
K222362 · NKB
Spine Wave, Inc.
Orthopedic · 25d
Cleared Aug 27, 2022
Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy...
K222449 · LZC
Better Care Plastic Technology Co., Ltd.
General Hospital · 12d
Cleared Aug 26, 2022
StimOnTM Pain Relief System (GM2439)
K213802 · GZJ
Gimer Medical Co., Ltd.
Neurology · 263d
Cleared Aug 26, 2022
Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO...
K214058 · GEI
Conmed Corporation
General & Plastic Surgery · 242d
Cleared Aug 26, 2022
Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
K220091 · FTL
Xiros, Ltd.
General & Plastic Surgery · 226d
Cleared Aug 26, 2022
Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope...
K220159 · FGB
Shanghai AnQing Medical Instrument...
Gastroenterology & Urology · 219d
Cleared Aug 26, 2022
Dimension EXL LOCI BRAHMS Procalcitonin (PCT)
K220262 · PRI
Siemens Healthcare Diagnostics, Inc.
Microbiology · 207d
Cleared Aug 26, 2022
MedCAD AccuShape Titanium Patient-Specific Cranial Implant
K220357 · GXN
Medcad
Neurology · 199d
Cleared Aug 26, 2022
BrainsWay Deep TMS System
K220819 · OBP
Brainsway , Ltd.
Neurology · 158d
Cleared Aug 26, 2022
HAcancellous PEEK-C Porous HA PEEK Cervical IBF System
K220875 · ODP
Innovasis, Inc.
Orthopedic · 154d
Cleared Aug 26, 2022
Upper Arm Blood Pressure Monitor
K221212 · DXN
Shenzhen Yolanda Technology Co., Ltd.
Cardiovascular · 121d
Cleared Aug 26, 2022
NEOVEIL Staple Line Reinforcement
K221487 · OXC
Gunze Limited
General & Plastic Surgery · 95d
Cleared Aug 26, 2022
BonOs® Inject Bone Cement
K222256 · PML
Neo Medical SA
Orthopedic · 30d
Cleared Aug 26, 2022
Arthrex Self Punching SwiveLock Suture Anchors
K222263 · MAI
Arthrex, Inc.
Orthopedic · 29d
Cleared Aug 26, 2022
BriefCase
K222277 · QAS
Aidoc Medical , Ltd.
Radiology · 28d
Cleared Aug 26, 2022
LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation
K222278 · JWH
Corentec Co., Ltd.
Orthopedic · 28d
Cleared Aug 25, 2022
WiEMSpro
K211298 · NGX
Medical Cables S.L.
Physical Medicine · 484d
Cleared Aug 25, 2022
MRI Planner
K211841 · MUJ
Spectronic Medical AB
Radiology · 437d