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
11377–11400 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 09, 1993
VANTAGE DIALTAION CATHETER
K934433 · LIT
Peripheral Systems Group
Cardiovascular · 87d
Cleared Dec 08, 1993
MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS
K932172 · DTB
Medtronic Vascular
Cardiovascular · 217d
Cleared Dec 08, 1993
SCIMED MAVERICK PTA CATHETER
K932537 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 196d
Cleared Dec 08, 1993
FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS
K933943 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 114d
Cleared Dec 08, 1993
FEP RINGED GORE-TEX VASCULAR GRAFT
K934726 · DYF
W.L. Gore & Associates, Inc.
Cardiovascular · 68d
Cleared Dec 07, 1993
PERITEMP PF 4005 HEATER
K932068 · DPW
Perimed, Inc.
Cardiovascular · 222d
Cleared Dec 07, 1993
AIRCAST EDEMAFLOW SYSTEM
K933977 · JOW
Aircast, Inc.
Cardiovascular · 116d
Cleared Dec 06, 1993
SPACE LABS MODEL 90560
K923788 · LOS
Spacelabs, Inc.
Cardiovascular · 496d
Cleared Dec 06, 1993
ENDOCATH ELECTROPHYSIOLOGY CATHETER
K926549 · DRF
Endo-Therapeutics, Inc.
Cardiovascular · 340d
Cleared Dec 06, 1993
CARAPACE ANGIOGRAPHY TRAYS
K931629 · DQO
Carapace, Inc.
Cardiovascular · 248d
Cleared Dec 03, 1993
PROFILOMAT
K932109 · DXN
Qmed, Inc.
Cardiovascular · 214d
Cleared Dec 03, 1993
MODEL IPM-1 IMPEDANCE PULSE MONITOR
K932438 · DSB
Electro-Diagnostic Instruments
Cardiovascular · 198d
Cleared Dec 03, 1993
ELECTROMEDICS BLOOD HEAT EXCHANGER
K934355 · DTR
Electromedics, Inc.
Cardiovascular · 87d
Cleared Dec 03, 1993
R AND D BATTERIES, INC. PART NUMBERS 5310, 5063 & 5211
K934660 · DSH
R & D Batteries, Inc.
Cardiovascular · 66d
Cleared Nov 24, 1993
VASCOTWIST 9/60
K920662 · DTB
Vascor Medical Corp.
Cardiovascular · 649d
Cleared Nov 24, 1993
SLIMLINE 3000
K934180 · DXQ
Pymah Corp.
Cardiovascular · 89d
Cleared Nov 24, 1993
CATHETER INTRODUCER MODIFICATION
K934285 · DYB
Daig Corp.
Cardiovascular · 89d
Cleared Nov 23, 1993
NDM SILVON ECG ELECTRODES
K931457 · DRX
Ndm Acquisition Corp.
Cardiovascular · 245d
Cleared Nov 23, 1993
STOPCOCK (ONE-PORT MANIFOLD)
K934123 · DTL
Merit Medical Systems, Inc.
Cardiovascular · 90d
Cleared Nov 23, 1993
IMPULSE 3000 DEFIBRILLATOR ANALYZER
K934254 · DRL
Dynatech/Nevada, Inc.
Cardiovascular · 84d
Cleared Nov 19, 1993
AFFINITY HOLLOW FIBER OXYGENATOR
K932252 · DTZ
Avecor Cardiovascular, Inc.
Cardiovascular · 177d
Cleared Nov 18, 1993
INTERMITTENT COMPRESSION SYSTEM MODEL 5000
K930526 · JOW
Advanced Instruments, Inc.
Cardiovascular · 289d
Cleared Nov 18, 1993
AMMEX TUBING ORGANIZER
K934782 · KRI
Ammex Cardiopulmonary Corp.
Cardiovascular · 43d
Cleared Nov 10, 1993
ULTRA THIN BALLOON DILATATION CATHETER
K924320 · LIT
Boston Scientific Corp
Cardiovascular · 440d