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
80665–80688 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 2000
IMPOAID
K000730 · LKY
Impoaid, Inc.
Gastroenterology & Urology · 227d
Cleared Oct 19, 2000
TREPCHEK TREPONEMAL ANTIBODY EIA
K001552 · LIP
Phoenix Biotech Corp.
Microbiology · 154d
Cleared Oct 19, 2000
GLOBAL SPINAL FIXATION SYSTEM
K001668 · MNH
D.K.M. Co., Ltd.
Orthopedic · 141d
Cleared Oct 19, 2000
THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD
K001795 · FOZ
Avitro, LLC
General Hospital · 127d
Cleared Oct 19, 2000
GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM
K002169 · MST
Scimedx Corp.
Immunology · 93d
Cleared Oct 19, 2000
GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM
K002189 · MST
Scimedx Corp.
Immunology · 92d
Cleared Oct 19, 2000
TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100
K002257 · GEI
Tecno Instruments (Pvt.) , Ltd.
General & Plastic Surgery · 86d
Cleared Oct 19, 2000
MDI GLIADIN A TEST
K002358 · MST
Micro Detect, Inc.
Immunology · 78d
Cleared Oct 19, 2000
MDI GLIADIN G TEST
K002359 · MST
Micro Detect, Inc.
Immunology · 78d
Cleared Oct 19, 2000
JETCAN HUBER NEEEDLE SET
K002471 · FPA
Pfm Produkte Fur Die Medizin AG
General Hospital · 69d
Cleared Oct 19, 2000
BIOMESH P1 AND BIOMESH PLUG AND PATCH
K002479 · FTL
Cousin Biotech S.A.R.L
General & Plastic Surgery · 69d
Cleared Oct 19, 2000
VITREA 2, VERSION 2.1
K002519 · LLZ
Vital Images, Inc.
Radiology · 65d
Cleared Oct 19, 2000
LUMALITE CURE LIGHT, MODEL 2100
K002566 · EBZ
Lumalite, Inc.
Dental · 63d
Cleared Oct 19, 2000
MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER
K002613 · CHL
Nova Biomedical Corp.
Chemistry · 58d
Cleared Oct 19, 2000
JEL BIOS PURE
K002645 · EJT
J.F. Jelenko & Co., Inc.
Dental · 56d
Cleared Oct 19, 2000
HARDYDISK NETILMICIN, 30MCG
K002663 · JTN
Hardy Diagnostics
Microbiology · 55d
Cleared Oct 19, 2000
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER
K002905 · MSW
Beckman Coulter, Inc.
Immunology · 31d
Cleared Oct 19, 2000
STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES
K002933 · KGO
Maxxim Medical
General Hospital · 29d
Cleared Oct 19, 2000
SPIRIT ACUPUNCTURE NEEDLE
K003010 · MQX
United Pacific Co., Ltd.
General Hospital · 23d
Cleared Oct 19, 2000
M2376A DEVICELINK SYSTEM
K003107 · MWI
Agilent Technologies, Inc.
Cardiovascular · 15d
Cleared Oct 19, 2000
SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE
K003225 · FPA
Baxter Healthcare Corp
General Hospital · 3d
Cleared Oct 18, 2000
GUNTHER TULIP VENA CAVA MREYE FILTER SET
K000855 · DTK
Cook, Inc.
Cardiovascular · 216d
Cleared Oct 18, 2000
TRANSQ3
K001522 · KTB
Iomed, Inc.
Physical Medicine · 155d
Cleared Oct 18, 2000
PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V
K002204 · DTE
Pace Medical
Cardiovascular · 90d