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
45337–45360 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 25, 2012
TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD
K111337 · FTL
Tornier, Inc.
General & Plastic Surgery · 258d
Cleared Jan 25, 2012
XENON(TM) PEDICLE SCREW SYSTEM
K111634 · NKB
Alphatec Spine, Inc.
Orthopedic · 226d
Cleared Jan 25, 2012
CARDIFF ANTERIOR CERVICAL PLATE SYSTEM
K112206 · KWQ
Seaspine, Inc.
Orthopedic · 177d
Cleared Jan 25, 2012
SWISSMEDA DENTAL PLANNING SYSTEM
K112251 · LLZ
Swissmeda AG
Radiology · 173d
Cleared Jan 25, 2012
THERATRODE
K112312 · GXY
Phoenix Medical Devices, Llp
Neurology · 167d
Cleared Jan 25, 2012
ENDOCHOICE WATER BOTTLE CAP SYSTEM
K112576 · FEQ
Endochoice, Inc.
Gastroenterology & Urology · 141d
Cleared Jan 25, 2012
SUN 125C IONIZATION CHAMBER
K112981 · LHN
Sun Nuclear Corp.
Radiology · 111d
Cleared Jan 25, 2012
DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC...
K113632 · IYO
Shenzhen Mindray Bio-Meidcal...
Radiology · 51d
Cleared Jan 25, 2012
SONIXTABLET ULTRASOUND SCANNER
K113663 · IYN
Ultrasonix Medical Corporation
Radiology · 43d
Cleared Jan 25, 2012
TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE
K113845 · DTL
Medtronic, Inc.
Cardiovascular · 28d
Cleared Jan 25, 2012
PANORAD, PANORAD SL
K113855 · KPR
Imix Adr Finland OY
Radiology · 27d
Cleared Jan 24, 2012
COBAS 4800 CT / NG TEST
K110923 · MKZ
Roche Molecular Systems, Inc.
Microbiology · 298d
Cleared Jan 24, 2012
EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND...
K111877 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 207d
Cleared Jan 24, 2012
AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL
K112705 · JJY
Aalto Scientific, Ltd.
Immunology · 130d
Cleared Jan 24, 2012
GENESIS TOUCH SYSTEM
K112858 · DRG
Honeywell Hommed, LLC
Cardiovascular · 116d
Cleared Jan 24, 2012
STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS
K112904 · FRG
Case Medical, Inc.
General Hospital · 112d
Cleared Jan 24, 2012
CONTIPLEX FX
K113059 · CAZ
B.Braun Medical, Inc.
Anesthesiology · 102d
Cleared Jan 24, 2012
IVAS BALLOON CATHETER
K113154 · NDN
Stryker Corporation
Orthopedic · 90d
Cleared Jan 24, 2012
MTF NEW BONE VOILD FILLER
K113167 · MQV
Musculoskeletal Transplant Foundation
Orthopedic · 89d
Cleared Jan 24, 2012
MEGABEAM ENDO-ENT PROBE
K113858 · GEX
Biolitec Medical Devices, Inc.
General & Plastic Surgery · 25d
Cleared Jan 23, 2012
RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3
K110534 · JJY
Randox Laboratories Limited
Chemistry · 332d
Cleared Jan 23, 2012
SYNDE-LOCK SYNDESMOSIS REPAIR KIT
K111971 · HWC
Tarsus Medical, Inc.
Orthopedic · 196d
Cleared Jan 23, 2012
PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT
K112574 · EMA
Prime Dental Manufacturing, Inc.
Dental · 139d
Cleared Jan 23, 2012
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
K112808 · DIO
Omega Laboratories, Inc.
Toxicology · 118d