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
125209–125232 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 1990
IMPRAFLO AUTOTRANSFUSION DEVICE
K901232 · CAC
Impra, Inc.
Anesthesiology · 126d
Cleared Jul 18, 1990
MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE
K901555 · DRX
Medtronic Vascular
Cardiovascular · 106d
Cleared Jul 18, 1990
MODEL 78834C NEONATAL PULSE OXIMETER (SAO2)
K901819 · DQA
Hewlett-Packard Co.
Anesthesiology · 86d
Cleared Jul 18, 1990
RED DOT 2269 INFANT MONITORING ELECTRODE
K902080 · DRX
3M Company
Cardiovascular · 71d
Cleared Jul 18, 1990
CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR
K902114 · BSK
Diemolding Corp.
Anesthesiology · 68d
Cleared Jul 18, 1990
THREADED PADDLE PAIRS, INTERNAL ADULT PEDI INFANT
K902590 · LDD
Marquette Electronics, Inc.
Cardiovascular · 36d
Cleared Jul 18, 1990
COBE CLOSED WOUND DRAINAGE KIT
K902759 · CAC
Cobe Laboratories, Inc.
Anesthesiology · 23d
Cleared Jul 18, 1990
ZEPPELIN INSTRUMENTS
K902850 · HAO
Ruggles Corp.
Neurology · 19d
Cleared Jul 17, 1990
TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC)
K884120 · BZQ
S & W Medico Teknik
Anesthesiology · 655d
Cleared Jul 17, 1990
PAGEWRITER XLI M1700A & PAGEWRITER XL M1701A
K895520 · LOS
Hewlett-Packard Co.
Cardiovascular · 308d
Cleared Jul 17, 1990
FOCUS J81F, J83F, J41F, J43F PACING LEADS
K896742 · DTB
Ela Medical, Inc.
Cardiovascular · 229d
Cleared Jul 17, 1990
SMALL VESSEL BALLOON DILATATION CATHETER
K897124 · LIT
Boston Scientific Corp
Cardiovascular · 203d
Cleared Jul 17, 1990
TRANS-PACE 100
K900220 · DTE
Synchromed Corp.
Cardiovascular · 181d
Cleared Jul 17, 1990
CBM-3000/CBM-2000/CBM-7000 BLOOD PRESSURE SYSTEM
K900247 · DXN
Colin Medical Instruments Corp.
Cardiovascular · 181d
Cleared Jul 17, 1990
ARTERIAL EMBOLECTOMY CATHETER
K900311 · DXE
Impra, Inc.
Cardiovascular · 176d
Cleared Jul 17, 1990
LEOCOR CORFLO(TM) PUMP
K900350 · DXK
Leocor, Inc.
Cardiovascular · 174d
Cleared Jul 17, 1990
MODIFIED NOVOSTE ANGIOGRAPHIC CATHETER
K900460 · DQO
Novoste Corp.
Cardiovascular · 168d
Cleared Jul 17, 1990
TRAM PATIENT MONITOR
K900540 · DSI
Marquette Electronics, Inc.
Cardiovascular · 162d
Cleared Jul 17, 1990
HYDRO-SIL(TM) COATED GUIDEWIRES
K900822 · DOX
National-Standard Medical Products
Toxicology · 146d
Cleared Jul 17, 1990
TECHNICON RA-2000(TM) SYSTEM
K901410 · JJC
Technicon Instruments Corp.
Chemistry · 113d
Cleared Jul 17, 1990
PREFILLED FLEXIBLE R.T. CONTAINERS W/STER. SODIUM
K901762 · BTT
Automatic Liquid Packaging, Inc.
Anesthesiology · 90d
Cleared Jul 17, 1990
FUKUDA DENSHI MODEL HJ-310
K901889 · DXN
Fukuda Denshi USA, Inc.
Cardiovascular · 82d
Cleared Jul 17, 1990
CARDISUNY 501AB
K901947 · DPS
Graham-Field, Inc.
Cardiovascular · 78d
Cleared Jul 17, 1990
CARDISUNY 501BIII
K901948 · DPS
Graham-Field, Inc.
Cardiovascular · 78d