FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
129889–129912 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 06, 1989
HAEMOPHILUS TEST MEDIUM (BROTH)
K894848 · JSO
Regional Media Laboratories
Microbiology · 37d
Cleared Sep 05, 1989
APACERAM ARTIFICIAL DENTAL IMPLANT
K885133 · DZE
Asahi Optical Co. C/O Rosati...
Dental · 267d
Cleared Sep 05, 1989
ECT-100 ELECTRONIC CORNEAL TOPOGRAPHER
K890687 · HLQ
Optimed, Inc.
Ophthalmic · 208d
Cleared Sep 05, 1989
LATEXCO LATEX EXAMINATION GLOVES
K891265 · LYY
Latex Products Co., Inc.
General Hospital · 181d
Cleared Sep 05, 1989
GENERAL IVT NEEDLE GUIDE KIT, STERILE
K892070 · HGL
Amedic USA
Obstetrics & Gynecology · 158d
Cleared Sep 05, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892080 · LYY
The Orient Connection
General Hospital · 155d
Cleared Sep 05, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892081 · LYY
Tacare Products , Ltd.
General Hospital · 155d
Cleared Sep 05, 1989
NON-STERILE VINYL EXAMINATION GLOVES
K892994 · LYZ
Sian-Yu Industrial Co., Ltd.
General Hospital · 146d
Cleared Sep 05, 1989
LANDSCAPE PATIENT EXAMINATION GLOVES
K893049 · LYY
Pacific Intl. Economic & Technical,...
General Hospital · 145d
Cleared Sep 05, 1989
RMI ULTRASOUND DOPPLER PHANTOM SYSTEM
K893216 · GXX
Radiation Measurements, Inc.
Neurology · 131d