FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
79513–79536 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 26, 2001
MEDIFACE PACS
K010259 · LLZ
Mediface Co., Ltd.
Radiology · 87d
Cleared Apr 26, 2001
THERASEED(R) PALLADIUM-103 IMPLANT
K010283 · KXK
Theragenics Corp.
Radiology · 86d
Cleared Apr 26, 2001
CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304
K010417 · KPT
Nuclear Assoc., Div. Inovision LP
Radiology · 73d
Cleared Apr 26, 2001
FREELITE LAMBDA FREE KIT
K010440 · DEH
The Binding Site, Ltd.
Immunology · 72d
Cleared Apr 26, 2001
FREELITE KAPPA FREE KIT
K010441 · DEH
The Binding Site, Ltd.
Immunology · 72d
Cleared Apr 26, 2001
PICCOLO CHLORIDE TEST SYSTEM
K010670 · CHJ
Abaxis, Inc.
Chemistry · 51d
Cleared Apr 26, 2001
MODIFICATION TO MIRAGE
K010726 · LLZ
Segami Corp., Inc.
Radiology · 45d
Cleared Apr 26, 2001
BMT ANSCORE HEALTH MANAGEMENT SYSTEM
K010955 · DPS
Boston Medical Technologies, Inc.
Cardiovascular · 27d
Cleared Apr 26, 2001
EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229
K010960 · DIC
Syva Co., Dade Behring, Inc.
Toxicology · 27d
Cleared Apr 26, 2001
EMIT II PLUS METHADONE ASSAY, MODEL OSRE229
K010962 · DJR
Syva Co., Dade Behring, Inc.
Toxicology · 27d
Cleared Apr 26, 2001
HARDYDISK BACITRACIN, 10MCG, MODEL Z927
K011086 · JTN
Hardy Diagnostics
Microbiology · 16d
Cleared Apr 25, 2001
GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005
K003206 · KXK
Proxima Therapeutics, Inc.
Radiology · 194d
Cleared Apr 25, 2001
ACTIVHEAL SCAR MANAGEMENT DRESSING
K010245 · MDA
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 90d
Cleared Apr 25, 2001
CRANIAL MOLDING ORTHOSIS
K010273 · MVA
Orthotic Solutions, Inc.
Neurology · 86d
Cleared Apr 25, 2001
NOVAMETRIX MARQUETTE COMPATIBLE SENSORS
K010451 · DQA
Novametrix Medical Systems, Inc.
Anesthesiology · 69d
Cleared Apr 25, 2001
SYNTHES (USA) IMF SCREWS
K010527 · DZL
Synthes (Usa)
Dental · 62d
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