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
80137–80160 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 2001
TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017
K010578 · BTT
Taga Medical Technologies, Inc.
Anesthesiology · 57d
Cleared Apr 25, 2001
BABY DOPPLEX 3000 MK 2 (BD3000)
K010889 · HGM
Huntleigh Healthcare, Inc.
Obstetrics & Gynecology · 30d
Cleared Apr 25, 2001
BABY DOPPLEX 3002 (BD3002)
K010894 · HGM
Huntleigh Healthcare, Inc.
Obstetrics & Gynecology · 30d
Cleared Apr 24, 2001
ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX
K000442 · KKX
Medical Concepts Development, Inc.
General Hospital · 439d
Cleared Apr 24, 2001
TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
K003558 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 158d
Cleared Apr 24, 2001
DOSIMETRY CHECK
K010225 · IYE
Math Resolutions, LLC
Radiology · 90d
Cleared Apr 24, 2001
MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K010536 · JTN
Oxoid , Ltd.
Microbiology · 60d
Cleared Apr 24, 2001
LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K010537 · JTN
Oxoid , Ltd.
Microbiology · 60d
Cleared Apr 24, 2001
VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428
K010550 · LTJ
bioMerieux, Inc.
Immunology · 57d
Cleared Apr 24, 2001
EUROSPITAL EU-TTG IGA UMANA
K010625 · MVM
Scimedx Corp.
Immunology · 53d
Cleared Apr 24, 2001
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K010627 · LYZ
Shijiazhuang Junfei Plastic Products...
General Hospital · 53d
Cleared Apr 24, 2001
ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS
K011081 · LPH
Exactech, Inc.
Orthopedic · 14d
Cleared Apr 24, 2001
PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST
K011116 · LTT
Pasco Laboratories, Inc.
Microbiology · 62d
Cleared Apr 23, 2001
SYNTHES SYNMESH SPACER SYSTEM
K003275 · MQP
Synthes (Usa)
Orthopedic · 186d
Cleared Apr 23, 2001
SHIELDING NEEDLE HOLDER
K003381 · FMI
U.S. Safety Syringes Co., Inc.
General Hospital · 174d
Cleared Apr 23, 2001
PASCO MIC AND MIC/ID PANELS
K010508 · LTT
Pasco Laboratories, Inc.
Microbiology · 61d
Cleared Apr 23, 2001
POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K010626 · LYZ
Shijiazhuang Junfei Plastic Products...
General Hospital · 52d
Cleared Apr 23, 2001
POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
K010628 · LYZ
Shijiazhuang Junfei Plastic Products...
General Hospital · 52d
Cleared Apr 23, 2001
MENTOR STERILE SALINE MAMMARY VOLUME SIZERS
K010709 · MRD
Mentor Corp.
General & Plastic Surgery · 45d
Cleared Apr 23, 2001
TAKE ONE BITE MODIFIED
K010994 · ELW
Kerr Corp.
Dental · 20d
Cleared Apr 20, 2001
ORIGEN BLADDER HOLDER
K003145 · DWC
Origen Biomedical, Inc.
Cardiovascular · 192d
Cleared Apr 20, 2001
SOFTLASE - SURGICAL DIODE LASER SYSTEM
K003440 · GEX
Zap Lasers, Inc.
General & Plastic Surgery · 165d
Cleared Apr 20, 2001
RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS
K003809 · DKZ
Rapid Diagnostics, Inc.
Toxicology · 133d
Cleared Apr 20, 2001
MODIFICATION TO CAVERMAP SURGICAL AID
K010213 · ETN
Uromed Corp.
Ear, Nose, Throat · 87d