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
47209–47232 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 2011
AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301
K101641 · LHQ
Ag Digital Technology Corp.
Radiology · 371d
Cleared Jun 16, 2011
BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX
K103476 · IZL
Ge Medical Systems, LLC
Radiology · 204d
Cleared Jun 16, 2011
GUARDACARE
K103641 · QSY
Hem Con Medical Technologies, Inc.
General & Plastic Surgery · 185d
Cleared Jun 16, 2011
ELTA WOUND CLEANSER
K103713 · FRO
Swiss American Products, Inc.
General & Plastic Surgery · 177d
Cleared Jun 16, 2011
EURO DEFI PADS ADULT
K103783 · LDD
Fiab Spa
Cardiovascular · 171d
Cleared Jun 16, 2011
TULA IONTOPHORESIS SYSTEM
K110636 · EGJ
Acclarent, Inc.
Physical Medicine · 104d
Cleared Jun 16, 2011
APEX K1 HIP STEM
K110947 · LPH
Omni Life Science, Inc.
Orthopedic · 73d
Cleared Jun 16, 2011
ENCOR ENSPIRE BREAST BIOPSY SYSTEM
K111100 · KNW
C.R. Bard, Inc.
Gastroenterology & Urology · 57d
Cleared Jun 16, 2011
SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)
K111297 · LYZ
Premier Medical Gloves Factory
General Hospital · 38d
Cleared Jun 16, 2011
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
K111459 · LYZ
Jiangsu Alfa Glove Co., Ltd.
General Hospital · 21d
Cleared Jun 16, 2011
MAXFIRE MARXMEN MENISCAL REPAIR DEVICE
K111564 · MBI
Biomet Sports Medicine
Orthopedic · 10d
Cleared Jun 15, 2011
ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT
K102274 · GAA
Arvik Enterprises/ Mini Lap Technologies
General & Plastic Surgery · 308d
Cleared Jun 15, 2011
COLONOSCOPY ASSISTANT
K102949 · FET
Sti Medical Systems, LLC
Gastroenterology & Urology · 253d
Cleared Jun 15, 2011
PONTO PRO POWER
K103594 · LXB
Oticon Medical AB
Ear, Nose, Throat · 189d
Cleared Jun 15, 2011
NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS
K110171 · NHA
Nobel Biocare USA, LLC
Dental · 146d
Cleared Jun 15, 2011
POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES
K110297 · LZA
Comfort Rubber Gloves Industries Sdn....
General Hospital · 134d
Cleared Jun 15, 2011
BIOSPINE VBR SYSTEM
K110864 · MQP
Aesculap Implant Systems, LLC
Orthopedic · 78d
Cleared Jun 15, 2011
VISENSIA, VISENSIA WITH ALERT
K110953 · MHX
Obs Medical
Cardiovascular · 71d
Cleared Jun 15, 2011
MD301C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR, L309TY
K111237 · LLZ
Nec Display Solutions , Ltd.
Radiology · 44d
Cleared Jun 15, 2011
AZUR DETACHABLE 35 PLATINUM COIL SYSTEM
K111307 · KRD
MicroVention, Inc.
Cardiovascular · 36d
Cleared Jun 14, 2011
HYDROFIX SURGICAL SHEET
K100313 · FTL
Mimedx Group, Inc.
General & Plastic Surgery · 495d
Cleared Jun 14, 2011
SPACELABS PATHFINDER SL HOLTER ANALYZER
K110001 · DQK
Spacelabs Healthcare, Ltd.
Cardiovascular · 162d
Cleared Jun 14, 2011
EV1000 CLINICAL PLATFORM
K110597 · DXG
Edwards Lifesciences
Cardiovascular · 104d
Cleared Jun 14, 2011
AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
K110599 · PHX
Tornier, Inc.
Orthopedic · 104d