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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
129289–129312 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 07, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892622 · LYY
Latexon Co., Ltd.
General Hospital · 150d
Cleared Sep 07, 1989
MODIFIED PRISTINE CULTURE CATHETER
K893390 · KOD
Hml Medical, Inc.
Gastroenterology & Urology · 129d
Cleared Sep 07, 1989
SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEM
K893811 · JQW
Sakura Finetek U.S.A., Inc.
Chemistry · 108d
Cleared Sep 07, 1989
ISOLIGHT
K894059 · EAZ
Eurodent, Inc.
Dental · 92d
Cleared Sep 07, 1989
ESSE QUATTRO/ESSE UNO
K894060 · KLC
Eurodent, Inc.
Dental · 92d
Cleared Sep 07, 1989
TRIGLYCERIDE (GPO) TRINDER REAGENT
K894063 · JGY
Sigma Diagnostics, Inc.
Chemistry · 91d
Cleared Sep 07, 1989
DEVON DISPOSABLE HEAD POSITIONER COVER
K894170 · KME
Devon Industries, Inc.
General Hospital · 84d
Cleared Sep 07, 1989
NOVA NUCLEUS CLINICAL CHEMISTRY SYSTEM
K894218 · JGS
Nova Biomedical Corp.
Chemistry · 80d
Cleared Sep 07, 1989
DSL 17A-OH PROGERSTERONE (DSL #6800)
K894265 · JLX
Diagnostic Systems Laboratories, Inc.
Chemistry · 77d
Cleared Sep 07, 1989
ACCESS TM
K894290 · LNH
Diasonics, Inc.
Radiology · 76d
Cleared Sep 07, 1989
LACTATE DEHYDROGENASE TEST (LD) ITEM #65418
K894482 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 51d
Cleared Sep 07, 1989
GLUCOSE-HK TEST (GLU-HK) ITEM #65415
K894483 · CFR
Em Diagnostic Systems, Inc.
Chemistry · 51d
Cleared Sep 07, 1989
ELSCINT'S EXEL 2400E CT SCANNER
K894542 · JAK
Elscint, Inc.
Radiology · 49d
Cleared Sep 07, 1989
FABFOAM #302
K894683 · JAD
Jewell Industries
Radiology · 44d
Cleared Sep 07, 1989
PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP
K894783 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 42d
Cleared Sep 07, 1989
HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB
K894838 · FKP
Baxter Healthcare Corp
Gastroenterology & Urology · 38d
Cleared Sep 06, 1989
SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT
K890913 · IYO
Shimadzu Precision Instruments, Inc.
Radiology · 194d
Cleared Sep 06, 1989
STERLING TENS
K891118 · GZJ
Armstrong Industries, Inc.
Neurology · 188d
Cleared Sep 06, 1989
STERILE SURGICAL NATURAL LATEX GLOVES
K891622 · KGO
Ct Intl.
General Hospital · 167d
Cleared Sep 06, 1989
ARVEE APNEA MONITOR, MODEL 2400
K891676 · BZQ
Arvee Medical, Inc.
Anesthesiology · 169d
Cleared Sep 06, 1989
CORRECT TOUCH SURGEONS GLOVES
K892176 · KGO
Ampri Rubberware Industries Sdn Bhd
General Hospital · 154d
Cleared Sep 06, 1989
STERILE LATEX SURGICAL GLOVES
K893899 · KGO
Life Force Laboratories, Inc.
General Hospital · 114d
Cleared Sep 06, 1989
LUMISCOPE MODEL 1000/APCC MODEL 1000
K894127 · GZJ
Lumiscope Co., Inc.
Neurology · 86d
Cleared Sep 06, 1989
MODIFIED LABELING TO PERMANENT LEAD INTRODUCER
K894431 · DYB
Daig Corp.
Cardiovascular · 51d