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
47833–47856 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 2011
TORFLEX TRANSSEPTAL GUIDING SHEATH
K102948 · DYB
Baylis Medical Co., Inc.
Cardiovascular · 178d
Cleared Apr 01, 2011
STERRAD CHEMICAL INDICATOR STRIP
K103218 · JOJ
Advanced Sterilization Products
General Hospital · 151d
Cleared Apr 01, 2011
STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K103219 · JOJ
Advanced Sterilization Products
General Hospital · 151d
Cleared CT Apr 01, 2011
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
K103595 · ETD
Acclarent, Inc.
Ear, Nose, Throat · 114d
Cleared Apr 01, 2011
EXPEDIUM SYSTEM, VIPER SYSTEM
K110216 · NKB
Depuy Spine, Inc.
Orthopedic · 66d
Cleared Apr 01, 2011
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K110522 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 37d
Cleared Apr 01, 2011
CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD
K110542 · LPH
Consensus Orthopedics, Inc.
Orthopedic · 36d
Cleared Apr 01, 2011
1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL
K110610 · MOS
Ge Medical Systems, LLC
Radiology · 29d
Cleared Apr 01, 2011
EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE /...
K110708 · PHX
Exactech, Inc.
Orthopedic · 18d
Cleared Apr 01, 2011
HYLATOPICPLUS CREAM
K110727 · FRO
Precision Dermatology Incorporated
General & Plastic Surgery · 16d
Cleared Apr 01, 2011
VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM
K110820 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 9d
Cleared Mar 31, 2011
EM-9000
K101482 · LNS
Elite Medical, Inc.
Gastroenterology & Urology · 307d
Cleared Mar 31, 2011
ZMACHINE, MODEL DT-100
K101830 · OLV
Consolidated Research of Richmond, Inc.
Neurology · 273d
Cleared Mar 31, 2011
TDS ABUTMENT FOR FRIADENT XIVE
K103339 · NHA
Pou YU Biotechnology Co., Ltd.
Dental · 136d
Cleared Mar 31, 2011
LAKONG ULTRASONIC SCALER
K103498 · ELC
Lakong Medical Device Company, Ltd.
Dental · 122d
Cleared Mar 31, 2011
A SCOPE
K103499 · DQD
Active Signal Technologies, Inc.
Cardiovascular · 122d
Cleared Mar 31, 2011
NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR)
K103670 · LZA
Innovative Gloves Co;, Ltd.
General Hospital · 105d
Cleared Mar 31, 2011
BPA-FREE PIT AND FISSURE SEALANT
K110058 · EBC
Novocol Inc. Dba Septodont and...
Dental · 80d
Cleared Mar 31, 2011
INSPIRA AIR BALLOON DILATION SYSTEM
K110218 · KTI
Acclarent, Inc.
Ear, Nose, Throat · 65d
Cleared Mar 31, 2011
INTELLIVUE PATIENT MONITOR
K110622 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 28d
Cleared Mar 31, 2011
ARTHREX BIOCOMPOSITE SUTURETAK
K110660 · MAI
Arthrex, Inc.
Orthopedic · 24d
Cleared Mar 31, 2011
SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE
K110796 · DYW
Biomers Products, LLC
Dental · 9d
Cleared Mar 30, 2011
ODFS PACE
K102115 · GZI
Odstock Medical, Ltd.
Neurology · 245d
Cleared Mar 30, 2011
SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM
K102402 · OVD
Alphatec Spine, Inc.
Orthopedic · 218d