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

Filters: Cleared only ×
176,076 results
62953–62976 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 2006
LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP
K060222 · NUH
Gemore Technology Co, Ltd.
Neurology · 88d
Cleared Apr 28, 2006
ANTHOGYR CONTRA ANGLES AND HANDPIECES
K060317 · EGS
Est. Anthogyr
Dental · 79d
Cleared Apr 28, 2006
NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002
K060336 · HAW
Orthosoft, Inc.
Neurology · 77d
Cleared Apr 28, 2006
KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR...
K060339 · NGT
Tyco Healthcare/Kendall
General Hospital · 77d
Cleared Apr 28, 2006
NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS
K060345 · CGA
Nova Biomedical Corp.
Chemistry · 77d
Cleared Apr 28, 2006
NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS
K060370 · JWH
Zimmer, Inc.
Orthopedic · 74d
Cleared Apr 28, 2006
V-505 INFA WARMER
K060461 · FMT
Atom Medical, Inc.
General Hospital · 65d
Cleared Apr 28, 2006
PREMISE FLOWABLE
K060472 · EBF
Kerr Corporation
Dental · 64d
Cleared Apr 28, 2006
SPECTRAGENICS ATS-1
K060567 · GEX
Spectragenics, Inc.
General & Plastic Surgery · 56d
Cleared Apr 28, 2006
ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS
K060577 · LZO
Ortho Development Corp.
Orthopedic · 53d
Cleared Apr 28, 2006
CONSENSUS ACETABULAR SHELL SYSTEM
K060635 · LPH
Hayes Medical, Inc.
Orthopedic · 49d
Cleared Apr 28, 2006
DSI PINS AND WIRES
K060654 · HTY
Delta Surgical Instruments, Inc.
Orthopedic · 46d
Cleared Apr 28, 2006
LIBERTY NORMAL GLUCOSE CONTROL SOLUTION
K060706 · JJX
Liberty Healthcare Group, Inc.
Chemistry · 43d
Cleared Apr 28, 2006
MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE...
K060743 · MEG
Safety Syringes, Inc.
General Hospital · 39d
Cleared Apr 28, 2006
BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS
K060761 · DJZ
Akers Biosciences, Inc.
Toxicology · 38d
Cleared Apr 28, 2006
SYNTHETIC VINYL PATIENT EXAMINATION GLOVE-POWDER FREE
K060778 · LYZ
Ever Light Plastic Products Co., Ltd.
General Hospital · 37d
Cleared Apr 28, 2006
MULTIDIRECTIONAL THREADED PEG
K060864 · LXT
Hand Innovations, LLC
Orthopedic · 29d
Cleared Apr 28, 2006
PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATION OF PARENTERAL...
K060866 · LHI
Carmel Pharma Ab.
General Hospital · 29d
Cleared Apr 28, 2006
ANGIODYNAMIC, INC. MORPHEUS CT PICC AND PROCEDURE KIT
K060887 · LJS
AngioDynamics, Inc.
General Hospital · 28d
Cleared Apr 28, 2006
CLEANER ROTATIONAL THROMBECTOMY SYSTEM
K060904 · MCW
Rex Medical, L.P.
Cardiovascular · 25d
Cleared Apr 28, 2006
IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE...
K060929 · CDD
Diagnostic Products Corporation
Chemistry · 23d
Cleared Apr 28, 2006
SYNCHRON SYSTEMS CREATININE (CREA) REAGENT
K060935 · CGX
Beckman Coulter, Inc.
Chemistry · 23d
Cleared Apr 28, 2006
SYNGO US WORKPLACE
K060992 · LLZ
Siemens Medical Solutions
Radiology · 17d
Cleared Apr 28, 2006
PLANAR DOME EX LINE MODEL DOME E2C
K061018 · LLZ
Planar Systems, Inc.
Radiology · 15d