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
128881–128904 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 1989
VAS-CATH URETERAL STENT CATHETER
K894357 · FAD
Vas-Cath, Inc.
Gastroenterology & Urology · 81d
Cleared Oct 03, 1989
ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT
K894394 · CFR
Abbott Laboratories
Chemistry · 78d
Cleared Oct 03, 1989
THERMALGRAPHIC ANALYSER
K894772 · HCS
Medtech Instruments
Neurology · 69d
Cleared Oct 03, 1989
BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE
K894791 · LKB
Span-America Medical Systems, Inc.
General Hospital · 67d
Cleared Oct 03, 1989
CARDIOBEEPER MEMORY MONITOR CB 600 SERIES
K894799 · DXH
Survival Technology, Inc.
Cardiovascular · 67d
Cleared Oct 03, 1989
PEDI-TUBE(R) STYLET
K894857 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 64d
Cleared Oct 03, 1989
SELECTRODE
K894920 · DRX
S & W Medico Teknik
Cardiovascular · 62d
Cleared Oct 03, 1989
STERILE SALINE - FOR SUCTION CATHETER LUBRICATION
K895039 · GCX
Aplicare, Inc.
General Hospital · 55d
Cleared Oct 03, 1989
ADD'L OPTIONS 1.5 TESLA & 1.0 TESLA TO MAGNETOM 42
K895221 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 67d
Cleared Oct 03, 1989
VALPROIC ACID (FPIA) KIT
K895569 · LEG
Tudor Laboratories, Inc.
Toxicology · 27d
Cleared Oct 03, 1989
FORTRESS MODEL 2200FS FRONT WHEEL DRIVE SCOOTER
K895694 · INI
Fortress Scientific , Ltd.
Physical Medicine · 11d
Cleared Oct 02, 1989
OLYMPUS HYF-P FLEXIBLE HYSTEROFIBERSCOPE
K891451 · HIH
Olympus Corp.
Obstetrics & Gynecology · 201d
Cleared Oct 02, 1989
FUKUDA DENSHI MODEL FCP-2201
K892796 · LOS
Fukuda Denshi USA, Inc.
Cardiovascular · 168d
Cleared Oct 02, 1989
HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM
K893094 · JOQ
Heartware Intl. Corp.
Cardiovascular · 157d
Cleared Oct 02, 1989
MODEL DS-504 DYNASCOPE PATIENT MONITOR
K893405 · DRT
Fukuda Denshi USA, Inc.
Cardiovascular · 153d
Cleared Oct 02, 1989
PCI MODEL 2041-A TELEMETRY MONITOR
K894340 · DXH
Accucore, Inc.
Cardiovascular · 80d
Cleared Oct 02, 1989
MODIFIED SOFTOUCH INTRODUCER W/HEMO VALVE & SIDE
K894445 · DYB
Mallinckroot, Inc.
Cardiovascular · 77d
Cleared Oct 02, 1989
SIEMENS SIRECUST 730, PATIENT MONITOR W/ARRHYTHMIA
K894460 · DSI
Siemens Medical Electronics
Cardiovascular · 76d
Cleared Oct 02, 1989
BEDSIDE MONITORS, BSM-8301A, BSM-8302A
K894692 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 70d
Cleared Oct 02, 1989
AP-851PA NIBP MODULE
K894693 · DXN
Nihon Kohden America, Inc.
Cardiovascular · 70d
Cleared Oct 02, 1989
TYPE 9140 (SYSTEM ATHENA)
K894699 · DRT
S & W Medico Teknik
Cardiovascular · 70d
Cleared Oct 02, 1989
TYPE PDU/CDU 9040 (SYSTEM ATHENA)
K894700 · DRT
S & W Medico Teknik
Cardiovascular · 70d
Cleared Oct 02, 1989
DERMASCAN C, AN ULTRASONIC DIAGNOSTIC SYSTEM
K894834 · IYO
Brymill Corp.
Radiology · 63d
Cleared Oct 02, 1989
VISION WHOLE BLOOD HDL CHOLESTEROL
K895158 · CHH
Abbott Laboratories
Chemistry · 53d