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
82249–82272 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 26, 2000
BIOLOK SCREW
K993630 · HWC
Encore Orthopedics, Inc.
Orthopedic · 182d
Cleared Apr 25, 2000
COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
K000255 · DTZ
Cobe Cardiovascular, Inc.
Cardiovascular · 88d
Cleared Apr 25, 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K000649 · GGP
Dade Behring, Inc.
Hematology · 57d
Cleared Apr 25, 2000
MOXIFLOXACIN, 5 UG, BBL SENSI-DISC
K000762 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 48d
Cleared Apr 25, 2000
STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109
K000964 · JOH
Automatic Liquid Packaging, Inc.
Anesthesiology · 29d
Cleared Apr 25, 2000
LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT...
K001021 · DTZ
Dideco S.P.A.
Cardiovascular · 26d
Cleared Apr 25, 2000
MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
K001118 · DFC
DiaSorin, Inc.
Chemistry · 18d
Cleared Apr 25, 2000
DATES-OHMEDA AESTIVA SMARTVENT MRI
K993410 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 196d
Cleared Apr 25, 2000
HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01
K994023 · FMF
Haemacure Corp.
General Hospital · 151d
Cleared Apr 24, 2000
ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD,...
K000297 · FHN
Erchinger Medizintecnik
Gastroenterology & Urology · 84d
Cleared Apr 24, 2000
RESPONSE 2000 HIP STEM
K000392 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 77d
Cleared Apr 24, 2000
VISION R/F TILTING TABLE
K000412 · IXR
Villa Sistemi Medicali S.P.A.
Radiology · 76d
Cleared Apr 24, 2000
RESPONSE 2000 CEMENTED HIP STEM
K000432 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 75d
Cleared Apr 24, 2000
REMOTE FETAL MEDICINE ULTRASOUND SYSTEM
K000443 · LLZ
R4 Telemedicine, Inc.
Radiology · 74d
Cleared Apr 24, 2000
SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST
K000452 · LAF
Drug Detection Devices, Ltd.
Toxicology · 73d
Cleared Apr 24, 2000
EVERSHEARS BIPOLAR SCISSORS
K000496 · GEI
Everest Medical Corp.
General & Plastic Surgery · 69d
Cleared Apr 24, 2000
MEDVIZER PACS, MODEL RELEASE 2000
K000557 · LLZ
Vitel Net
Radiology · 66d
Cleared Apr 24, 2000
ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE
K000612 · KNW
Inrad
Gastroenterology & Urology · 61d
Cleared Apr 24, 2000
MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM...
K000985 · LYY
Matang Mfg. Sdn. Bhd.
General Hospital · 28d
Cleared Apr 24, 2000
GE LOGIQ 700
K001016 · ITX
GE Medical Systems
Radiology · 26d
Cleared Apr 24, 2000
MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS
K001105 · KWP
Depuyacromed
Orthopedic · 19d
Cleared Apr 24, 2000
VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2
K001133 · KHS
Ortho-Clinical Diagnostics, Inc.
Chemistry · 14d
Cleared Apr 24, 2000
LORAD LT-100 LASER TREATMENT SYSTEM
K992597 · GEX
Focus Medical, LLC
General & Plastic Surgery · 265d
Cleared Apr 21, 2000
KSEA CHARDONNES MORCELLATION KNIFE
K000212 · KOH
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 88d