FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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 · Free access · No registration required

Filters: Cardiovascular ×
18,151 results
16921–16944 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 22, 1980
MICRO THIN-PII, #0523
K802353 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 88d
Cleared Dec 22, 1980
UNIPOLAR ENDOCARDIAL LASER DRILLED ELEC
K802968 · DTB
Telectronics, Inc.
Cardiovascular · 31d
Cleared Dec 22, 1980
ELECATH FLUID-DRAIN ASSEMBLY
K803002 · DQR
Electro-Catheter Corp.
Cardiovascular · 27d
Cleared Dec 22, 1980
MICROTHIN-PII BIPOLAR PULSE GEN. #0623
K803034 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 21d
Cleared Dec 22, 1980
MICROTHIN-PII BIPOLAR PULSE GEN. #0621
K803035 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 21d
Cleared Dec 22, 1980
SIEMENS-ELEMA ENDOCARDIAL LEAD 402S
K803042 · DTB
Siemens Elema AB
Cardiovascular · 21d
Cleared Dec 22, 1980
INTERSEPT* VENOUS RESERVOIR BAG & HOLDER
K803059 · DTN
Extracorporeal Medical Specialities,...
Cardiovascular · 19d
Cleared Dec 22, 1980
PREBYPASS FILTER CAT.#K-5
K803101 · KRJ
Delta Medical Industries
Cardiovascular · 13d
Cleared Dec 22, 1980
ARTERIAL BUBBLE TRAP K-20
K803102 · KRL
Delta Medical Industries
Cardiovascular · 13d
Cleared Dec 19, 1980
BUCKBERG-SHILEY BLOOD CARDIOPLEGIC SPL.
K802879 · DTR
Shiley, Inc.
Cardiovascular · 32d
Cleared Dec 19, 1980
6-415 FILTER, ELEMENT, 170-C
K802925 · DSK
Lifecare Services, Inc.
Cardiovascular · 30d
Cleared Dec 19, 1980
PRESSURE MONITORING SET
K802945 · DQO
Norton Performance Plastics Corp.
Cardiovascular · 30d
Cleared Dec 16, 1980
UNIFOCAL VP, MODELS 7501 AND 7502
K800746 · DXY
American Pacemaker Corp.
Cardiovascular · 257d
Cleared Dec 16, 1980
PUIG MASSANA-SHILEY ANNULOPLASTY RING
K801879 · KRH
Shiley, Inc.
Cardiovascular · 132d
Cleared Dec 16, 1980
BLOOD PRESSURE UNIT MODEL 310
K802411 · DXN
Js & A Group
Cardiovascular · 74d
Cleared Dec 16, 1980
BLOOD PRESSURE UNIT MODEL 410
K802412 · DXN
Js & A Group
Cardiovascular · 74d
Cleared Dec 16, 1980
SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S
K802719 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 46d
Cleared Dec 16, 1980
SPIRAFLO BLOOD OXYGENATORS MODEL BOS-5S
K802720 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 46d
Cleared Dec 16, 1980
OXYGEN SATURATION METER MODEL NO. SM-1
K802847
Bentley Laboratories, Inc.
Cardiovascular · 34d
Cleared Dec 16, 1980
TECNOL TELEMETRY UNIT POUCH
K802849 · DRG
Tecnol New Jersey Wound Care, Inc.
Cardiovascular · 34d
Cleared Dec 16, 1980
WILLIAM HARVEY OXYGENATING GAS FILTER
K802906 · KRI
C.R. Bard, Inc.
Cardiovascular · 29d
Cleared Dec 11, 1980
CARDIOPLEGIA COOLING SYST. CCAS-2
K802848 · DTR
Bentley Laboratories, Inc.
Cardiovascular · 29d
Cleared Dec 10, 1980
MILLAR MIKRO-TIP CATHETER PHONOTRANS
K802830 · DXW
Millar Instruments, Inc.
Cardiovascular · 30d
Cleared Dec 01, 1980
INTERMEDICS' LIFELINE TLE ENDOCARDIAL
K801172 · DTB
Intermedics, Inc.
Cardiovascular · 199d