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
81169–81192 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 2000
BACT/ALERT CSR
K003104 · LJF
Organon Teknika Corp.
Microbiology · 52d
Cleared Oct 20, 2000
MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS
K003121 · IYO
Medison America, Inc.
Radiology · 15d
Cleared Oct 20, 2000
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
K003125 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Oct 20, 2000
VISIJET HYDROKERATOME, MODEL 50
K991124 · MYD
Visijet, Inc.
Ophthalmic · 567d
Cleared Oct 20, 2000
BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/...
K994276 · LZA
Biopro (M) Sdn Bhd
General Hospital · 305d
Cleared Oct 20, 2000
BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION GLOVES (GRREN,...
K994281 · LZA
Biopro (M) Sdn Bhd
General Hospital · 305d
Cleared Oct 20, 2000
CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES
K994320 · NCZ
Cantor & Silver , Ltd.
Ophthalmic · 303d
Cleared Oct 19, 2000
0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE
K000632 · FOZ
Avitro, LLC
General Hospital · 238d
Cleared Oct 19, 2000
MACROPOREMX MANDIBULAR FIXATION SYSTEM
K000696 · JEY
Macropore Biosurgery, Inc.
Dental · 232d
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