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
75217–75240 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 10, 2002
OCTEIA 25-HYDROXY VITAMIN D
K021163 · MRG
Immunodiagnostic Systems , Ltd.
Chemistry · 29d
Cleared May 10, 2002
GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER
K021258 · MCF
Germ Terminator Corporation
Dental · 21d
Cleared May 10, 2002
AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL
K021413 · ELW
Dentsply Intl.
Dental · 7d
Cleared May 09, 2002
CHROMAGEN V3.0 READING AID SOFT CONTACT LENS
K012132 · NIC
Cantor & Nissel , Ltd.
Ophthalmic · 304d
Cleared May 09, 2002
MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING
K013053 · LKY
Nanma Mfg Co., Ltd.
Gastroenterology & Urology · 240d
Cleared May 09, 2002
MICROJET CRONO H
K013855 · FRN
Cane S.R.I.
General Hospital · 170d
Cleared May 09, 2002
DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)
K020430 · NFK
Diatek, Inc.
Gastroenterology & Urology · 90d
Cleared May 09, 2002
INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
K020535 · HEB
Rostam , Ltd.
Obstetrics & Gynecology · 79d
Cleared May 09, 2002
OHMEDA MEDICAL GIRAFFE OMNIBED
K020543 · FMZ
Ohmeda Medical
General Hospital · 79d
Cleared May 09, 2002
OHMEDA MEDICAL GIRAFFE INCUBATOR
K020547 · FMZ
Ohmeda Medical
General Hospital · 79d
Cleared May 09, 2002
SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN
K020561 · IYO
Tomtec Imaging Systems GmbH
Radiology · 78d
Cleared May 09, 2002
FUJIREBIO DIAGNOSTICS CA 19-9 RIA
K020566 · NIG
Fujirebio Diagnostics,Inc.
Immunology · 78d
Cleared May 09, 2002
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K020709 · KWP
Medtronic Sofamor Danek
Orthopedic · 65d
Cleared May 09, 2002
DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131
K020724 · MRR
Dade Behring, Inc.
Chemistry · 64d
Cleared May 09, 2002
GATIFLOXIN
K020762 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 63d
Cleared May 09, 2002
MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME
K020820 · JWY
Dade Behring, Inc.
Microbiology · 57d
Cleared May 09, 2002
VORTEX VALVED HOLDING CHAMBER
K020944 · CAF
Pari Innovative Manufacturers, Inc.
Anesthesiology · 45d
Cleared May 09, 2002
CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER
K021054 · LMC
Codonics, Inc.
Radiology · 38d
Cleared May 09, 2002
MODEL 2120IS SERIES MATERNAL/FETAL MONITOR
K021135 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 30d
Cleared May 09, 2002
ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR
K021166 · FDC
Acmi-Circon Corporation
Gastroenterology & Urology · 28d
Cleared May 09, 2002
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE
K021339 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 63d
Cleared May 08, 2002
NORAV HOLTER SYSTEM, MODEL NH-300 V1.07
K012712 · MLO
Norav Medical , Ltd.
Cardiovascular · 267d
Cleared May 08, 2002
COMPRESSIBLE LIMB SLEEVE
K012979 · JOW
Medical Device Services, Inc.
Cardiovascular · 245d
Cleared May 08, 2002
QFLOW 500 PERFUSION MONITORING SYSTEM
K013376 · DPW
Hemedex Incorporated
Cardiovascular · 209d