FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
10057–10080 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 28, 1997
A-V IMPULSE SYSTEM MODEL 6060
K964425 · JOW
Powell,Goldstein,Frazer & Murphy
Cardiovascular · 265d
Cleared Jul 28, 1997
CARD GUARD, MODEL CG-7100
K964836 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 241d
Cleared Jul 28, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP
K971604 · DSH
Alexander Mfg. Co.
Cardiovascular · 88d
Cleared Jul 25, 1997
PERCUTANEOUS VENOUS INTRODUCER 10264
K965167 · DYB
Medamicus, Inc.
Cardiovascular · 213d
Cleared Jul 25, 1997
ARROW-TREROTOLA PTD CATHETER
K970080 · MCW
Arrow Intl., Inc.
Cardiovascular · 197d
Cleared Jul 25, 1997
ANNULOFLO SYSTEM
K970375 · KRH
Carbomedics, Inc.
Cardiovascular · 172d
Cleared Jul 24, 1997
MEDI-TECH 4 AND 5 FRENCH NIGHTHAWK FLUSH ANGIOGRAPHIC CATHETERS
K971607 · DQO
Boston Scientific Corp
Cardiovascular · 84d
Cleared Jul 23, 1997
CAMOUFLAGE CUFF SAVERS
K963987 · DXQ
N.A. Braggs Medical, Inc.
Cardiovascular · 292d
Cleared Jul 23, 1997
POSEIDON CARDIAC MONITORING SYSTEM (PCMS)
K964408 · DPS
Instromedix, Inc.
Cardiovascular · 261d
Cleared Jul 23, 1997
ENVOY GUIDING CATHETER
K965247 · DQY
Cordis Neurovascular, Inc.
Cardiovascular · 211d
Cleared Jul 23, 1997
INTRODUCER SHEATH AND DILATOR
K971165 · LDF
Boston Scientific Corp
Cardiovascular · 114d
Cleared Jul 23, 1997
CORDIS POWERFLEX PLUS PTA BALLOON CATHETER
K971516 · LIT
Cordis Corp.
Cardiovascular · 86d
Cleared Jul 23, 1997
COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR
K971669 · DTN
Cobe Cardiovascular, Inc.
Cardiovascular · 78d
Cleared Jul 23, 1997
SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97)
K971968 · DSA
Remington Medical, Inc.
Cardiovascular · 56d
Cleared Jul 22, 1997
MODEL 6495 BIPOLAR TEMPORARY PACING LEAD
K963898 · LDF
Medtronic Vascular
Cardiovascular · 298d
Cleared Jul 21, 1997
UNI-GRAFT K DV
K963790 · DSY
Atrium Medical Corp.
Cardiovascular · 304d
Cleared Jul 21, 1997
CHASE VESSEL CANNULA
K971019 · DWF
Chase Medical, Inc.
Cardiovascular · 123d
Cleared Jul 21, 1997
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K971608 · DYB
Cordis Corp.
Cardiovascular · 81d
Cleared Jul 18, 1997
CARDIOMAGIC 2000 SOFTWARE
K964036 · DXH
Instromedix, Inc.
Cardiovascular · 283d
Cleared Jul 18, 1997
CORDIS OPTA 5 PTA BALLOON CATHETER
K971579 · LIT
Cordis Corp.
Cardiovascular · 88d
Cleared Jul 15, 1997
NIHON KOHDEN TEC-7531 CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES
K971355 · LDD
Nihon Kohden America, Inc.
Cardiovascular · 95d
Cleared Jul 14, 1997
COBE CENTURY PERFUSION PUMP
K960974 · DWB
Cobe Cardiovascular, Inc.
Cardiovascular · 490d
Cleared Jul 14, 1997
FG INFUSION CATHETER
K971306 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 97d
Cleared Jul 14, 1997
MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL
K971474 · DTE
Medtronic Vascular
Cardiovascular · 82d