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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,151 results
11257–11280 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 12, 1994
BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM
K934899 · DTD
Telectronics Pacing Systems, Inc.
Cardiovascular · 210d
Cleared May 12, 1994
WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD
K935403 · DQO
J-Lloyd Medical, Inc.
Cardiovascular · 184d
Cleared May 12, 1994
ENDOSURG DISPOSABLE SECONDARY TROCAR
K940036 · DRC
Endosurg
Cardiovascular · 128d
Cleared May 12, 1994
ONTRAC STEERABLE GUIDEWIRE
K941229 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 58d
Cleared May 10, 1994
AFFINITY VENOUS RESERVIOR BAG
K935717 · DTN
Avecor Cardiovascular, Inc.
Cardiovascular · 161d
Cleared May 06, 1994
SCIMED 10 FR LARGE LUMEN TRIGUIDE-FLEX GUID CATH
K940545 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 88d
Cleared May 05, 1994
EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR
K935590 · JOQ
Ep Medical, Inc.
Cardiovascular · 168d
Cleared May 04, 1994
520 DISPLAY DRIVER- STATUS I
K926298 · DRT
Vidco, Inc.
Cardiovascular · 506d
Cleared May 04, 1994
MEDTRONIC GCIII CORONARY GUIDING CATHETER
K935738 · DQY
Medtronics Interventional Vascular
Cardiovascular · 154d
Not Cleared May 04, 1994
DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III
K940824 · DYF
W.L. Gore & Associates, Inc.
Cardiovascular · 118d
Cleared May 03, 1994
MISCELLANEOUS PACING LEAD
K925168 · DTD
Oscor Medical Corp.
Cardiovascular · 567d
Cleared May 03, 1994
FLOW DIRECTED THERMODILUTION BALLOON CATHETER
K935404 · DYG
J-Lloyd Medical, Inc.
Cardiovascular · 175d
Cleared May 03, 1994
ACS POWERBASE(TM) CORONARY GUIDING CATHETER
K940559 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 85d
Cleared May 02, 1994
MINIX/MINIX ST PULSE GENERATORS
K932884 · DXY
Medtronic Vascular
Cardiovascular · 322d
Not Cleared May 02, 1994
MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF
K933055 · DTB
Medtronic Vascular
Cardiovascular · 340d
Not Cleared May 02, 1994
DIASTAT VASCULAR ACCESS GRAFT
K940062 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 116d
Cleared Apr 26, 1994
ANGIOGRAPHIC BALLOON CATHETER BY J-LLOYD
K935402 · DQO
J-Lloyd Medical, Inc.
Cardiovascular · 168d
Cleared Apr 26, 1994
METRONIC BUCHBINDER ENVOY PERCUTANEOUS CATHETERS
K935425 · DQY
Medtronics Interventional Vascular
Cardiovascular · 167d
Cleared Apr 26, 1994
MANUAL STETOSCOPE
K940578 · LDE
Bhs Intl., Inc.
Cardiovascular · 77d
Cleared Apr 25, 1994
ZYMED HOLTER SCANNER MODEL 2010
K930806 · DQK
Agilent Technologies
Cardiovascular · 433d
Cleared Apr 19, 1994
MARQUETTE EAGLE MONITOR
K920790 · DSI
Marquette Electronics, Inc.
Cardiovascular · 788d
Cleared Apr 19, 1994
SCIMED 8 FRENCH TRIGUIDE GUIDING CATHETER
K940603 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 69d
Cleared Apr 19, 1994
INNERSENSE DISPOSABLE MICROTRANSDUCER
K941283 · DXO
Becton Dickinson Vascular Access, Inc.
Cardiovascular · 33d
Cleared Apr 15, 1994
MODEL ELI 300 ELECTROCARDIOGRAPH
K933143 · LOS
Mortara Instrument, Inc.
Cardiovascular · 291d