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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
49465–49488 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 2010
SHIMADZU COLLIMATOR R-300
K101039 · IZW
Shimadzu Corp.
Radiology · 159d
Cleared Sep 20, 2010
MODEL SB100II FINGER PULSE OXIMETER
K101568 · DQA
Atlantean
Anesthesiology · 110d
Cleared Sep 20, 2010
BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS
K101589 · DWJ
Cincinnati Sub-Zero Products, Inc.
Cardiovascular · 105d
Cleared Sep 20, 2010
EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004
K101688 · KKX
Exact Medical Manufacturing, Inc.
General Hospital · 96d
Cleared Sep 20, 2010
EMM EQUIPMENT COVER-POLYTHYLENE
K101689 · KKX
Exact Medical Manufacturing, Inc.
General Hospital · 96d
Cleared Sep 20, 2010
ALBOSURE POLYESTER VASCULAR PATCH
K101740 · DXZ
LeMaitre Vascular, Inc.
Cardiovascular · 91d
Cleared Sep 20, 2010
RELINE-IT MODEL RELINE-IT
K101771 · EBP
Majestic Drug Co., Inc.
Dental · 88d
Cleared Sep 20, 2010
SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
K102017 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 63d
Cleared Sep 20, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534
K102356 · DXN
Andon Health Co, Ltd.
Cardiovascular · 32d
Cleared Sep 17, 2010
BABY QUASAR
K091467 · ONE
Silver Bay, LLC
General & Plastic Surgery · 487d
Cleared Sep 17, 2010
REVIVATOR
K094003 · BTM
Hersill, S.L.
Anesthesiology · 263d
Cleared Sep 17, 2010
V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY...
K100657 · OMP
Kci USA, Inc. (Kinetic Concepts, Inc.)
General & Plastic Surgery · 193d
Cleared Sep 17, 2010
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
K100787 · FTL
Smith & Nephew, Inc.
General & Plastic Surgery · 182d
Cleared Sep 17, 2010
E-BASIC SINGLE BREAST PUMP
K101157 · HGX
Mapa GmbH
Obstetrics & Gynecology · 144d
Cleared Sep 17, 2010
ACUTE INNOVATIONS STERNAL FIXATION SYSTEM
K101170 · KTT
Acute Innovations, LLC
Orthopedic · 144d
Cleared Sep 17, 2010
ULTRASEAL ID
K101245 · EBC
Ultradent Products, Inc.
Dental · 136d
Cleared Sep 17, 2010
I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V)
K101366 · NUV
Chromogenex Technologies, Ltd.
General & Plastic Surgery · 123d
Cleared Sep 17, 2010
GC FUJI TEMP
K101420 · EMA
GC America, Inc.
Dental · 120d
Cleared Sep 17, 2010
CO2 LASER SYSTEM
K101555 · GEX
Advanced Technology Laser Co., Ltd.
General & Plastic Surgery · 105d
Cleared Sep 17, 2010
SHAPE TO FIT COMPRESSION WEAR
K101906 · DWL
Tsung Hau Technology Co., Ltd.
General Hospital · 71d
Cleared Sep 17, 2010
CRYO-TOUCH II
K102021 · GXH
Myoscience, Inc.
Neurology · 60d
Cleared Sep 17, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513
K102353 · DXN
Andon Health Co, Ltd.
Cardiovascular · 29d
Cleared Sep 16, 2010
ITOTAL CR KNEE REPLACEMENT SYSTEM
K094050 · JWH
Conformis, Inc.
Orthopedic · 259d
Cleared Sep 16, 2010
ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK
K101129 · CBK
Respironics, Inc.
Anesthesiology · 147d