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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
66073–66096 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 2005
DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX
K040501 · NUN
Musculoskeletal Transplant Foundation
Dental · 428d
Cleared Apr 29, 2005
ATHENA MULTI-LYTE EBV IGG TEST SYSTEM
K042118 · JRY
Zeus Scientific, Inc.
Microbiology · 266d
Cleared Apr 29, 2005
EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM
K043245 · CGA
Eps Bio Technology Corp.
Chemistry · 157d
Cleared Apr 29, 2005
LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE
K043604 · DQK
Vivometrics, Inc.
Cardiovascular · 121d
Cleared Apr 29, 2005
DIODENT II DENTAL LASER SYSTEM
K050274 · GEX
Hoya Photonics, Inc.
General & Plastic Surgery · 81d
Cleared Apr 29, 2005
THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)
K050350 · HPT
Notal Vision, Inc.
Ophthalmic · 77d
Cleared Apr 29, 2005
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000
K050369 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 74d
Cleared Apr 29, 2005
REM440
K050496 · ETW
Interacoustics A/S, Assens
Ear, Nose, Throat · 60d
Cleared Apr 29, 2005
UCP RAPID DRUG SCREENING TESTS
K050540 · DKZ
Ucp Biosciences, Inc.
Toxicology · 58d
Cleared Apr 29, 2005
LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)
K050682 · DIF
Bio-Rad Laboratories, Inc.
Toxicology · 44d
Cleared Apr 29, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/ML
K050745 · LON
Becton, Dickinson & CO
Microbiology · 38d
Cleared Apr 29, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, LEVOFLOXACIN (STREP) 0.25-16 UG/ML
K050747 · LON
Becton, Dickinson & CO
Microbiology · 38d
Cleared Apr 29, 2005
ELECTRODE JUNCTION BOX, MODEL JE-921A
K050833 · OLV
Nihon Kohden America, Inc.
Neurology · 28d
Cleared Apr 29, 2005
MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS
K050950 · GEX
Active Optical Systems, Ltd./Efraim...
General & Plastic Surgery · 14d
Cleared Apr 29, 2005
VISION-SCIENCES ENT-3000 SCOPE
K050972 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 11d
Cleared Apr 29, 2005
DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS
K050974 · DRQ
Draeger Medical Systems, Inc.
Cardiovascular · 11d
Cleared Apr 28, 2005
COMPEL SURGICAL GOWNS
K041539 · FYA
Standard Textile Co., Inc.
General Hospital · 324d
Cleared Apr 28, 2005
NITI-S STENT & INTRODUCER, MODEL EOXXXX
K041648 · ESW
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 315d
Cleared Apr 28, 2005
RX90 LOW PROFILE ACETABULAR SYSTEM
K042989 · LPH
Biomet, Inc.
Orthopedic · 181d
Cleared Apr 28, 2005
D-CARIE, MODEL N121-M1
K043156 · NBL
Neks Technologies, Inc.
Dental · 164d
Cleared Apr 28, 2005
CERAMAGE
K050401 · EBF
Shofu Dental Corp.
Dental · 70d
Cleared Apr 28, 2005
ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4
K050768 · MRX
Hamilton Thorne Biosciences
Obstetrics & Gynecology · 34d
Cleared Apr 28, 2005
ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER
K050794 · QEZ
Possis Medical, Inc.
Cardiovascular · 30d
Cleared Apr 27, 2005
AIP INTENSE PULSED LIGHT SYSTEM
K041554 · GEX
Aesthera Corporation
General & Plastic Surgery · 321d