Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
48721–48744 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2010
COWELL IMPLANT SYSTEM
K100850 · DZE
Cowellmedi Co., Ltd.
Dental · 269d
Cleared Dec 20, 2010
INERTIA PEDICLE SCREW SYSTEM
K101278 · MNH
Nexxt Spine, LLC
Orthopedic · 228d
Cleared Dec 20, 2010
ENDURO KNEE SYSTEM
K101815 · KRO
Aesculap Implant Systems
Orthopedic · 173d
Cleared Dec 20, 2010
SUNMAX VIETNAM CO. LTD POWDER FREE WHITE NITRILE EXAMINATION GLOVE
K101870 · LZA
Sunmax Vietnam Co., Ltd.
General Hospital · 167d
Cleared Dec 20, 2010
RHEAD RADIAL HEAD EXTENDED STEMS
K102180 · JDB
Small Bone Innovations, Inc.
Orthopedic · 140d
Cleared Dec 20, 2010
SYNTHETIC, POWDER-FREE NITRILE EXAMINATION
K102593 · LYZ
Zibo Yinghao Medical Products Co., Ltd.
General Hospital · 102d
Cleared Dec 20, 2010
MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE
K102641 · JEY
Neoortho Produtos Ortopedicos S/A
Dental · 98d
Cleared Dec 20, 2010
SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM
K102656 · JEY
Synthes (Usa)
Dental · 96d
Cleared Dec 20, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K102724 · LYZ
Zibo Yuqun New Material Science and...
General Hospital · 90d
Cleared Dec 20, 2010
DANA REUSABLE TEST PACK FOR STEAM STERILIZATION
K102761 · JOJ
Dana Products, Inc.
General Hospital · 88d
Cleared Dec 20, 2010
TWISTCUT ENDOSORB SCREWS
K102777 · JDW
Merete Medical GmbH
Orthopedic · 87d
Cleared Dec 20, 2010
CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT
K102875 · GWM
Integra LifeSciences Corporation
Neurology · 80d
Cleared Dec 20, 2010
HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON
K102889 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 81d
Cleared Dec 20, 2010
IMC PISTON SYRINGES
K102969 · FMF
International Medsurg Connection
General Hospital · 75d
Cleared Dec 20, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K102977 · LYZ
Heze Juxinyuan Food Co., Ltd.
General Hospital · 75d
Cleared Dec 20, 2010
ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM
K102981 · DZE
Ace Surgical Supply Company, Inc.
Dental · 74d
Cleared Dec 20, 2010
PRELUDE II TOUNGE SUSPENSION SYSTEM
K103179 · ORY
Siesta Medical, Inc.
Dental · 53d
Cleared Dec 20, 2010
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK
K103189 · LZO
Medacta International S.A.
Orthopedic · 53d
Cleared Dec 20, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K103198 · LYZ
Youngshengplastic Co., Ltd.
General Hospital · 52d
Cleared Dec 17, 2010
HIGH PRESSURE SETS-400 PSI
K100576 · FPA
Icu Medical, Inc.
General Hospital · 291d
Cleared Dec 17, 2010
SMARTO
K101563 · KIJ
Jeil Medical Corporation
Orthopedic · 196d
Cleared Dec 17, 2010
NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION
K102106 · DRG
Nihon Kohden Corp.
Cardiovascular · 143d
Cleared Dec 17, 2010
PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE
K102709 · GEI
Peak Surgical, Inc.
General & Plastic Surgery · 88d
Cleared Dec 17, 2010
REGIONAL OXIMETER
K102715 · MUD
Nonin Medical, Inc.
Cardiovascular · 88d