FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
79009–79032 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
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