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
60265–60288 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 2007
LC THERAPY, MODEL LCT-1000
K070400 · ILY
Litecure, LLC
Physical Medicine · 16d
Cleared Feb 27, 2007
PALOMAR LUX1540 HANDPIECE
K061652 · GEX
Palomar Medical Products, Inc.
General & Plastic Surgery · 259d
Cleared Feb 27, 2007
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE...
K062764 · LZC
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 165d
Cleared Feb 27, 2007
SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM
K062789 · JEY
Synthes (Usa)
Dental · 162d
Cleared Feb 27, 2007
PRECISION OXYGEN MONITOR
K063096 · CCL
Precision Medical, Inc.
Anesthesiology · 140d
Cleared Feb 27, 2007
ELECTRIC POWERED WHEELCHAIR, MODEL - RUMBA SR (4R)
K063307 · ITI
Imc-Heart Way LLC
Physical Medicine · 118d
Cleared Feb 27, 2007
ELECTRIC POWERED LIFT WHEELCHAIR, MODEL VISION (P13)
K063320 · ITI
Imc-Heart Way LLC
Physical Medicine · 117d
Cleared Feb 27, 2007
BIOMET TIBIAL LOCKING NAIL SYSTEM
K063570 · HSB
Biomet Manufacturing Corp
Orthopedic · 90d
Cleared Feb 27, 2007
ADAPTER PS RP-NP, 34551, ADAPTER PS WP-RP,34552, ABUTMENT SCREW PS RP-NP,...
K063592 · NHA
Nobel Biocare AB
Dental · 85d
Cleared Feb 27, 2007
COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163
K063696 · FRN
Baxterhealthcare, Inc.
General Hospital · 76d
Cleared Feb 27, 2007
PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE
K063755 · MEG
Smiths Medical Asd, Inc.
General Hospital · 70d
Cleared Feb 27, 2007
SYNGO DYNAMICS, VERSION 6.0
K070322 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 25d
Cleared Feb 26, 2007
DIASORIN LIAISON VZV IGG
K061820 · LFY
DiaSorin, Inc.
Microbiology · 243d
Cleared Feb 26, 2007
HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM
K062256 · IMI
Hill Laboratories Co.
Physical Medicine · 206d
Cleared Feb 26, 2007
SURGINETICS ADVANTAGEBLADE
K062350 · GEI
Surginetics
General & Plastic Surgery · 199d
Cleared Feb 26, 2007
ORIGEN DBM WITH BIOACTIVE GLASS
K062459 · MQV
Nanotherapeutics
Orthopedic · 187d
Cleared Feb 26, 2007
CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS CS40B, CS40G, CR40B AND CR40G
K062869 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 154d
Cleared Feb 26, 2007
ATLAS SPINE VERTEBRAL BODY REPLACEMENT
K063205 · MQP
Atlas Spine, LLC
Orthopedic · 126d
Cleared Feb 26, 2007
MEDELA DOMINANT 50 LIPO, MODEL 600-5706
K063336 · QPB
Medela AG
General & Plastic Surgery · 112d
Cleared Feb 26, 2007
CAPTION APPLICATOR
K063535 · FMF
Smith & Nephew, Inc.
General Hospital · 96d
Cleared Feb 26, 2007
GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS
K063562 · OTP
Ethicon, Inc.
Obstetrics & Gynecology · 91d
Cleared Feb 26, 2007
SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT
K063857 · MBB
Howmedica Osteonics Corp.
Orthopedic · 60d
Cleared Feb 26, 2007
BALANCE REHABILITATION UNIT (BRU)
K070085 · LXV
Medicaa (Uruguay) S.A.
Ear, Nose, Throat · 48d
Cleared Feb 26, 2007
GC FUJI IX GP EXTRA
K070319 · EMA
GC America, Inc.
Dental · 24d