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
54961–54984 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 2008
REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP...
K082546 · DQA
Unimed Medical Supplies, Inc.
Anesthesiology · 90d
Cleared Dec 01, 2008
PROSIT WOUND TREATMENT DEVICE
K081977 · FRO
Silverleaf Medical Products, Inc.
General & Plastic Surgery · 143d
Cleared Dec 01, 2008
DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER
K082208 · NAC
Scivolutions, Inc.
General & Plastic Surgery · 118d
Cleared Dec 01, 2008
VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600
K082456 · IYO
Verathon Incorporated
Radiology · 97d
Cleared Dec 01, 2008
COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE
K082535 · GAT
Surgical Devices, A Global Business...
General & Plastic Surgery · 90d
Cleared Nov 28, 2008
DDS STABILIZATION SYSTEM
K080241 · NQP
Paradigm Spine, LLC
Orthopedic · 302d
Cleared Nov 28, 2008
TABATABA COTESTER
K080278 · CCJ
Fim Medical
Anesthesiology · 298d
Cleared Nov 28, 2008
MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458
K082011 · GZJ
Bio-Medical Research, Ltd.
Neurology · 136d
Cleared Nov 28, 2008
MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM
K082172 · HSX
Mako Surgical Corporation
Orthopedic · 119d
Cleared Nov 28, 2008
GE ENTROPY SENSOR
K082540 · GXY
Ge Healthcare
Neurology · 87d
Cleared Nov 28, 2008
SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP,...
K082674 · FMF
Spectra Medical Devices, Inc.
General Hospital · 74d
Cleared Nov 26, 2008
SI JOINT FUSION SYSTEM
K080398 · OUR
SI-BONE, Inc.
Orthopedic · 287d
Cleared Nov 26, 2008
RAPIDVIT AND RAPIDWARM CLEAVE
K080446 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 281d
Cleared Nov 26, 2008
OMNI-DL SYSTEM
K080650 · KDI
Transvivo, Inc.
Gastroenterology & Urology · 264d
Cleared Nov 26, 2008
RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01...
K081975 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 138d
Cleared Nov 26, 2008
HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM
K082541 · CAF
Medi Nuclear Corp., Inc.
Anesthesiology · 85d
Cleared Nov 26, 2008
OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL...
K082600 · CBK
Draeger Medical B.V.
Anesthesiology · 79d
Cleared Nov 26, 2008
FETAL & MATERNAL MONITOR, MODEL F6, F9
K082602 · HGM
Edan Instruments, Inc.
Obstetrics & Gynecology · 79d
Cleared Nov 26, 2008
AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE,...
K082730 · OTP
American Medical Systems, Inc.
Obstetrics & Gynecology · 69d
Cleared Nov 26, 2008
GC AADVA ZR DISK
K082740 · EIH
GC America, Inc.
Dental · 69d
Cleared Nov 26, 2008
NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES
K082785 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 64d
Cleared Nov 26, 2008
INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997
K082888 · DQA
Draeger Medical Systems, Inc.
Anesthesiology · 57d
Cleared Nov 26, 2008
VERITAS COLLAGEN MATRIX (DRY)
K083039 · FTM
Synovis Surgical Innovations
General & Plastic Surgery · 43d
Cleared Nov 26, 2008
QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200
K083078 · DXN
Quanta Computer, Inc.
Cardiovascular · 41d