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
63073–63096 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 2006
BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE
K052843 · FMI
Busse Hospital Disposables, Inc.
General Hospital · 192d
Cleared Apr 17, 2006
BILISOFT PHOTOTHERAPY SYSTEM
K053568 · LBI
Lumitex, Inc.
General Hospital · 116d
Cleared Apr 17, 2006
APEXCAL
K060365 · EJK
Ivoclar Vivadent, Inc.
Dental · 63d
Cleared Apr 14, 2006
G4, MODEL IGM-0004
K051651 · NBW
U. S. Diagnostics, Inc.
Chemistry · 297d
Cleared Apr 14, 2006
GREEN LOVE MALE CONTRACEPTIVE (CONDOM)
K051842 · HIS
Cupid Condom, Ltd.
Obstetrics & Gynecology · 281d
Cleared Apr 14, 2006
KELO-COTE SPRAY
K053481 · MDA
Advanced Bio-Technologies, Inc.
General & Plastic Surgery · 121d
Cleared Apr 14, 2006
GUAVA EZCD4 SYSTEM
K053497 · GKZ
Guava Technologies, Inc.
Hematology · 120d
Cleared Apr 14, 2006
DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE...
K053577 · MMI
Dade Behring, Inc.
Chemistry · 113d
Cleared Apr 14, 2006
FDS INTIMATE AND INTIMATE WARMING LUBRICANT
K060145 · NUC
Alberto-Culver USA, Inc.
Obstetrics & Gynecology · 85d
Cleared Apr 14, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN - 0.5-64 UG/ML
K060257 · LON
Becton, Dickinson & CO
Microbiology · 72d
Cleared Apr 14, 2006
SHERLOCK TIP LOCATION SYSTEM (TLS)
K060341 · FOZ
C.R. Bard, Inc.
General Hospital · 63d
Cleared Apr 14, 2006
ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10
K060359 · JIT
Denka Seiken Co., Ltd.
Chemistry · 60d
Cleared Apr 14, 2006
LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM
K060533 · MSS
Lenstec, Inc.
Ophthalmic · 45d
Cleared Apr 14, 2006
ACCLAIM TOTAL ELBOW SYSTEM
K060696 · JDC
DePuy Orthopaedics, Inc.
Orthopedic · 29d
Cleared Apr 14, 2006
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K060719 · MQP
Medtronic Sofamor Danek
Orthopedic · 28d
Cleared Apr 14, 2006
VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE...
K060873 · MOS
Sentinelle Medical, Inc.
Radiology · 15d
Cleared Apr 14, 2006
GALILEOS
K060892 · MUH
Sirona Dental Systems GmbH
Radiology · 11d
Cleared Apr 13, 2006
PICSI SPERM SELECTION DEVICE
K052457 · MQK
Biocoat, Inc.
Obstetrics & Gynecology · 218d
Cleared Apr 13, 2006
INTERMEZZO PLUS FIXTURE
K053354 · DZE
Megagen Co., Ltd.
Dental · 132d
Cleared Apr 13, 2006
LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING
K053589 · MSD
Bard Access Systems, Inc.
Gastroenterology & Urology · 111d
Cleared Apr 13, 2006
CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED...
K060231 · FMG
Elcam Medical Acal
General Hospital · 73d
Cleared Apr 13, 2006
NORIAN CRS FAST SET PUTTY
K060443 · GXP
Synthes (Usa)
Neurology · 51d
Cleared Apr 13, 2006
NORIAN CRS BONE CEMENT
K060445 · GXP
Synthes (Usa)
Neurology · 51d
Cleared Apr 13, 2006
HEMOGLOBIN ALC CONTROL
K060570 · JJX
Compass Bioscience
Chemistry · 38d