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
16105–16128 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 2021
Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove
K201592 · KGO
Cardinal Health200, LLC
General Hospital · 471d
Cleared Sep 26, 2021
Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter,...
K202459 · CAH
Pharma System AB
General Hospital · 395d
Cleared Sep 26, 2021
DT100 Digital Thermometer
K203731 · FLL
Smart Technology Co., Ltd.
General Hospital · 279d
Cleared Sep 26, 2021
Surgical Mask
K210908 · FXX
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 181d
Cleared Sep 26, 2021
DiscCath Needle Set
K212328 · BSP
Disccath, LLC
Anesthesiology · 61d
Cleared Sep 24, 2021
IV Administration Sets
K202618 · FPA
B.Braun Medical, Inc.
General Hospital · 379d
Cleared Sep 24, 2021
Personal Lubricant
K210857 · NUC
Shenzhen Huanqiu Xuebao Technology...
Obstetrics & Gynecology · 185d
Cleared Sep 24, 2021
Encore Hip Stem
K211505 · MEH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 133d
Cleared Sep 24, 2021
DRI Cocaine Metabolite Assay
K211973 · DIO
Microgenics Corporation
Toxicology · 91d
Cleared Sep 24, 2021
Red Wave Hair Removal
K212099 · ONF
Shenzhen Accompany Technology Co., Ltd.
General & Plastic Surgery · 80d
Cleared Sep 24, 2021
Dynamic TiBase
K212108 · NHA
Talladium Espa?a, SL
Dental · 80d
Cleared Sep 24, 2021
Nobel Biocare Dental Implant Systems Portfolio - MR Conditional
K212125 · DZE
Nobel Biocare AG
Dental · 79d
Cleared Sep 24, 2021
Virtual C DRF-NEO Digital Imaging System
K212557 · OWB
Portavision Medical, LLC
Radiology · 42d
Cleared Sep 24, 2021
Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic...
K212704 · IYN
Philips Medical Systems
Radiology · 29d
Cleared Sep 24, 2021
ViperCross Support Catheters
K212725 · DQY
Cardiovascular Systems, Inc.
Cardiovascular · 28d
Cleared Sep 24, 2021
Collaboration Live
K212777 · LLZ
Philips Ultrasound, Inc.
Radiology · 23d
Cleared Sep 23, 2021
ABC Dental Implant System
K202092 · DZE
Abracadabra Implants , Ltd.
Dental · 422d
Cleared Sep 23, 2021
TorrentX Wound Wash
K203446 · FRO
Next Science, LLC
General & Plastic Surgery · 304d
Cleared Sep 23, 2021
Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11
K203662 · FLL
Yibin Junxin Electronics Technology...
General Hospital · 282d
Cleared Sep 23, 2021
Automatic Digital Blood Pressure Monitor
K210152 · DXN
Aviche Shandong Medical Technology...
Cardiovascular · 245d
Cleared Sep 23, 2021
Sterile Hypodermic Needles for Single Use
K210232 · FMI
Zhejiang Kangkang Medical-Devices...
General Hospital · 238d
Cleared Sep 23, 2021
One Touch Spiral Condom
K210294 · HIS
Thai Nippon Rubber Industry Public...
Obstetrics & Gynecology · 233d
Cleared Sep 23, 2021
OnGuard2 Chemfort Closed Administration (CADM)
K210707 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 197d
Cleared Sep 23, 2021
Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)
K211667 · LAZ
Changzhou Universal Medical Equipment...
General & Plastic Surgery · 114d