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
9025–9048 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 18, 2000
M2376A DEVICELINK SYSTEM, MODEL M2376A
K002967 · MWI
Agilent Technologies, Inc.
Cardiovascular · 26d
Cleared Oct 13, 2000
ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER
K001578 · DQO
AngioDynamics, Inc.
Cardiovascular · 144d
Cleared Oct 13, 2000
HL168B
K002882 · DXN
Health & Life Co., Ltd.
Cardiovascular · 28d
Cleared Oct 13, 2000
SAFE MINI
K980974 · DTZ
Polystan A/S
Cardiovascular · 942d
Cleared Oct 10, 2000
MODEL 4815 ADAPTER
K002496 · DTN
Pace Medical
Cardiovascular · 57d
Cleared Oct 10, 2000
MODEL 4810 ANALYZER OUTPUT ADAPTER
K002497 · DTC
Pace Medical
Cardiovascular · 57d
Cleared Oct 05, 2000
CATHCOR DESKTOP
K002137 · DQK
Siemens Elema AB
Cardiovascular · 83d
Cleared Oct 05, 2000
S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08
K002478 · MHX
Datex-Ohmeda, Inc.
Cardiovascular · 55d
Cleared Oct 05, 2000
ELS CANNULA (KIT), MODEL M1210-88,M1510-88
K002857 · DWF
Jostra AG
Cardiovascular · 22d
Cleared Oct 04, 2000
AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES
K002074 · DPS
H&C Medical Devices Spa
Cardiovascular · 86d
Cleared Oct 04, 2000
INQWIRE DIAGNOSTIC GUIDE WIRE
K002289 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 69d
Cleared Oct 04, 2000
PRESSURE WIRE SENSOR, MODEL 12003/12303
K002962 · DQX
Radi Medical Systems AB
Cardiovascular · 12d
Cleared Sep 28, 2000
REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS
K002723 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 28d
Cleared Sep 27, 2000
WIRE, GUIDE, CATHETER, MODEL QSW1000
K002346 · DQX
Medtronic Ave, Inc.
Cardiovascular · 56d
Cleared Sep 27, 2000
COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE
K002767 · DXC
Semler Technologies, Inc.
Cardiovascular · 21d
Cleared Sep 27, 2000
TYSHAK, MODEL 102 AND Z-MED, MODEL 302
K991977 · LIT
NuMED, Inc.
Cardiovascular · 474d
Cleared Sep 26, 2000
CONSTELLATION CATHETERS
K000277 · MTD
Boston Scientific Corp
Cardiovascular · 239d
Cleared Sep 26, 2000
OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010
K000512 · DXQ
Cas Medical Systems, Inc.
Cardiovascular · 223d
Cleared Sep 26, 2000
BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D
K001244 · DXN
Citizen Watch Co., Ltd.
Cardiovascular · 161d
Cleared Sep 26, 2000
OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES
K002030 · MWI
Invivo Research, Inc.
Cardiovascular · 85d
Cleared Sep 26, 2000
CLOUD CUFF
K002360 · DXQ
Parts Port, Ltd.
Cardiovascular · 54d
Cleared Sep 25, 2000
ILT 0.014 CATHETER, MODEL C114NL2
K001992 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 88d
Cleared Sep 22, 2000
VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD...
K001926 · DYB
Thoratec Laboratories Corp.
Cardiovascular · 88d
Cleared Sep 21, 2000
4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER
K000825 · DQO
Medi-Dyne, Inc.
Cardiovascular · 191d