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
70393–70416 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 2004
ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM
K033286 · HSB
Orthopedic Designs, Inc. (Odi)
Orthopedic · 90d
Cleared Jan 12, 2004
MEDICAL MAGGOTS
K033391 · NQK
Ronald A. Sherman
General & Plastic Surgery · 81d
Cleared Jan 12, 2004
ACL TOP MODEL, TOP
K033414 · GKP
Instrumentation Laboratory CO
Hematology · 77d
Cleared Jan 12, 2004
DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR,...
K033525 · DCF
Dade Behring, Inc.
Chemistry · 66d
Cleared Jan 12, 2004
BOSTON SCIENTIFIC V-18 CONTROL WIRE
K033742 · DQX
Boston Scientific Corp
Cardiovascular · 45d
Cleared Jan 12, 2004
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K033929 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 25d
Cleared Jan 09, 2004
BATTERY PACK, RECHARGEABLE, MODELS MLA0051, MLA90479, MNC5169L/P, MNC1000EKG,...
K032051 · MKJ
Access Battery, Inc.
Cardiovascular · 191d
Cleared Jan 09, 2004
TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM
K032585 · HDC
Ron-Tech Medical , Ltd.
Radiology · 141d
Cleared Jan 09, 2004
CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT
K032710 · KOD
Apogee Medical, Inc.
Gastroenterology & Urology · 129d
Cleared Jan 09, 2004
DIAMOND SETUP 2000
K032886 · LHN
K&S Assoc., Inc.
Radiology · 115d
Cleared Jan 09, 2004
PREPAIR
K033215 · KOJ
Danville Materials, Inc.
Dental · 98d
Cleared Jan 09, 2004
ACQSIM-MULTISLICE-CT, MODEL 453567042271
K033357 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 81d
Cleared Jan 09, 2004
SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS
K033372 · HCG
Micro Therapeutics, Inc.
Neurology · 79d
Cleared Jan 09, 2004
FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L
K033377 · LMC
Fujifilm Medical System U.S.A., Inc.
Radiology · 79d
Cleared Jan 09, 2004
SPIRIT 5000 CARDIAC COIL
K033490 · MOS
Usa Instruments, Inc.
Radiology · 66d
Cleared Jan 09, 2004
OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218
K033830 · EZL
Opticon Medical, Inc.
Gastroenterology & Urology · 30d
Cleared Jan 08, 2004
ARIOL HER-2/NEU IHC
K031715 · NOT
Applied Imaging Corp.
Pathology · 220d
Cleared Jan 08, 2004
NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS
K031962 · JWH
Implex Corp.
Orthopedic · 197d
Cleared Jan 08, 2004
PROMOS SHOULDER
K032126 · HSD
Plus Orthopedics
Orthopedic · 182d
Cleared Jan 08, 2004
ASAP SINUSCOPE...
K032822 · EOB
Asap Endoscopic Products GmbH
Ear, Nose, Throat · 120d
Cleared Jan 08, 2004
PINNACLE REVISION SYSTEM
K033338 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 83d
Cleared Jan 08, 2004
DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GREEN COLOR
K033539 · LYZ
Shen Wei (Usa), Inc.
General Hospital · 59d
Cleared Jan 08, 2004
CO2 CALIBRATOR/DILUENT
K033643 · JIT
Bayer Healthcare, Diagnostics Division
Chemistry · 49d
Cleared Jan 08, 2004
SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR
K033683 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 45d