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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
12745–12768 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 06, 1990
3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100
K900605 · DTD
Possis Medical, Inc.
Cardiovascular · 26d
Cleared Feb 28, 1990
INSITUCAT VALVE STRIPPER
K885046 · DWQ
Aesculap Instruments Corp.
Cardiovascular · 450d
Cleared Feb 28, 1990
PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV
K890182 · DSY
Aesculap Instruments Corp.
Cardiovascular · 406d
Cleared Feb 28, 1990
DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR
K893711 · DTN
Shiley, Inc.
Cardiovascular · 286d
Cleared Feb 28, 1990
UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF
K894826 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 212d
Cleared Feb 28, 1990
ACCESSOR PERIPHERAL DILATING GUIDE WIRE
K895179 · LIT
Peripheral Systems Group
Cardiovascular · 202d
Cleared Feb 28, 1990
CATHETER BALLOON DILATOR PRESSURE GAUGE
K895511 · MAV
Argon Medical Corp.
Cardiovascular · 169d
Cleared Feb 28, 1990
KING OF HEARTS 1200 MONITOR
K896039 · DXH
Instromedix, Inc.
Cardiovascular · 135d
Cleared Feb 28, 1990
SCHNEIDER MONORAIL-PMC PRESSURE MONITORING CATH.
K896741 · DQO
Schneider Intl., Ltd.
Cardiovascular · 90d
Cleared Feb 28, 1990
ACS INDEFLATOR XX
K896849 · MAV
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 85d
Cleared Feb 28, 1990
CLOSED CHEST SUPPORT CIRCUIT W/BIO-ACTIVE SURFACE
K896978 · DTZ
Medtronic Vascular
Cardiovascular · 77d
Cleared Feb 27, 1990
RMI AORTIC ROOT PRESSURE MONITOR EXTENSION LINE
K896777 · DWF
Research Medical, Inc.
Cardiovascular · 88d
Cleared Feb 27, 1990
RMI VASOPLEGIA CANNULA WITH & WITHOUT CHECK VALVE
K896778 · DWF
Research Medical, Inc.
Cardiovascular · 88d
Cleared Feb 26, 1990
DUAL GUIDE INTRODUCER CATHETER
K895044 · DYB
Cook, Inc.
Cardiovascular · 201d
Cleared Feb 26, 1990
LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES)
K895379 · LDD
Physio-Control Corp.
Cardiovascular · 180d
Cleared Feb 26, 1990
SMALL CATHETER INFLATOR
K896005 · MAV
Allied Systems Co.
Cardiovascular · 136d
Cleared Feb 26, 1990
EKG, ECG KENZ, ECG 302
K896771 · DSI
Cambridge Medical Instruments, Inc.
Cardiovascular · 87d
Cleared Feb 26, 1990
EKG, ECG KENZ, ECG 303
K896772 · DPS
Cambridge Medical Instruments, Inc.
Cardiovascular · 87d
Cleared Feb 26, 1990
CANYON MEDICAL FEMORAL BYPASS CANNULAE AND INTRO.
K897026 · DWF
Canyon Medical Products
Cardiovascular · 69d
Cleared Feb 22, 1990
TELECTRONICS PACING SYSTEMS VS-1 TO 6MM UPSIZING
K895971 · DTD
Telectronics Pacing Systems, Inc.
Cardiovascular · 132d
Cleared Feb 22, 1990
CRAGG CONVERTIBLE WIRE
K897152 · DQX
Boston Scientific Corp
Cardiovascular · 58d
Cleared Feb 16, 1990
FLAT VASCULAR PROBE
K896613 · DPW
Imex Medical Systems, Inc.
Cardiovascular · 87d
Cleared Feb 15, 1990
ULTRAMARK 7 ULTRASOUND SYSTEM
K896543 · DXK
Advanced Technology Laboratories, Inc.
Cardiovascular · 90d
Cleared Feb 15, 1990
RMI ANTEPLEGIA CANNULA
K896636 · DWF
Research Medical, Inc.
Cardiovascular · 85d