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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
12361–12384 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 30, 2022
Arrow Stiffening Stylet
K220280 · DRB
Arrow International, LLC (A...
Cardiovascular · 210d
Cleared Aug 30, 2022
SaliPen
K220618 · QTT
Saliwell , Ltd.
Dental · 180d
Cleared Aug 30, 2022
JR Medic
K221157 · LZC
Jr Engineering & Medical Technologies...
General Hospital · 131d
Cleared Aug 30, 2022
Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use...
K221164 · LZA
Hong Seng Gloves Sdn Bhd
General Hospital · 130d
Cleared Aug 30, 2022
INDEX BPM
K221486 · DXN
Ya Horng Electronic Co., Ltd.
Cardiovascular · 99d
Cleared Aug 30, 2022
Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine &...
K221618 · OLO
Brainlab AG
Orthopedic · 88d
Cleared Aug 30, 2022
Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM)...
K221871 · NFT
Healstone Biotech, Inc.
Toxicology · 63d
Cleared Aug 30, 2022
Lancing device
K221970 · QRL
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 56d
Cleared Aug 30, 2022
Ultrasound Transmission Gels
K221999 · MUI
Hony Medical Co., Ltd.
Radiology · 54d
Cleared Aug 30, 2022
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
K222558 · PBK
Centers For Disease Control and...
Microbiology · 6d
Cleared Aug 29, 2022
GlucoLeader Enhance 2 Blood Glucose Monitoring System
K212248 · NBW
Hmd Biomedical, Inc.
Chemistry · 406d
Cleared Aug 29, 2022
Leaderflex Mini and Leaderflex Nano
K212370 · FOZ
Vygon USA
General Hospital · 395d
Cleared Aug 29, 2022
Blood Pressure Monitor
K220676 · DXN
Guangdong Transtek Medical...
Cardiovascular · 174d
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