Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

96 results for "Pacesetter Systems"
73–96 of 96
Search insights Median review: 60d Cleared: 100% Top manufacturer: Pacesetter Systems Lead specialty: Cardiovascular
Cleared Oct 29, 1981
MODEL 841 ENDOCARDIAL TINED LEAD
K812816 · DTB
Pacesetter Systems
Cardiovascular · 22d
Cleared Oct 29, 1981
MODEL 833 ENDOCARDIAL TINED LEAD
K812815 · DTB
Pacesetter Systems
Cardiovascular · 22d
Cleared Aug 13, 1981
PACEPATH IMPLANTABLE ENDOCARD. PACING LD
K811200 · DTB
Pacesetter Systems
Cardiovascular · 105d
Cleared Apr 23, 1981
PACEMAKER LEAD ADAPTER
K810551 · DTD
Pacesetter Systems
Cardiovascular · 52d
Cleared Mar 13, 1981
ELECTRODE, PACEMAKER PERMANENT
K810582 · DTB
Pacesetter Systems
Cardiovascular · 10d
Cleared Oct 31, 1980
PACEMAKER LEAD ADAPTOR MODEL 431
K802407 · DTD
Pacesetter Systems
Cardiovascular · 28d
Cleared Oct 31, 1980
PACEPATH MODEL 810
K801416 · DTB
Pacesetter Systems
Cardiovascular · 137d
Cleared Oct 23, 1980
LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM
K801455 · DTB
Pacesetter Systems
Cardiovascular · 121d
Cleared Oct 23, 1980
PACEPATH MODEL 819
K801417 · DTB
Pacesetter Systems
Cardiovascular · 129d
Cleared Sep 26, 1980
PROGRAMALITH #'S 221, 222, 221A & 222A
K801978 · DXY
Pacesetter Systems
Cardiovascular · 38d
Cleared Aug 27, 1980
VIVALITH 5, - MDL-201A & TDL-201A
K801763 · DXY
Pacesetter Systems
Cardiovascular · 30d
Cleared Sep 20, 1979
MODEL 221 PROGRAMALITH PULSE GENERATOR
K790873 · DXY
Pacesetter Systems
Cardiovascular · 136d
Cleared Sep 04, 1979
MODELS UL-804 AND BL-801 UNIPOLAR LEADS
K791552 · DTB
Pacesetter Systems
Cardiovascular · 21d
Cleared Aug 10, 1979
MDL-201A & T DL-201A PULSE GENERATOR
K790428 · DXY
Pacesetter Systems
Cardiovascular · 162d
Cleared Aug 10, 1979
BIPOLAR LEAD ADAPTOR, MODEL BA-415
K790218 · DTD
Pacesetter Systems
Cardiovascular · 192d
Cleared Aug 10, 1979
PULSE GENERATOR, R WAVE DEMAND
K790141 · DXY
Pacesetter Systems
Cardiovascular · 203d
Cleared Oct 27, 1978
PACING LEADS MODEL UL-811 AND UL-813
K781776 · DTB
Pacesetter Systems
Cardiovascular · 14d
Cleared Sep 27, 1978
GENERATORS: UDL-201B, BDL-201B, MDL-201B
K781424 · DXY
Pacesetter Systems
Cardiovascular · 41d
Cleared Jan 30, 1978
MDL-201
K772051 · DXY
Pacesetter Systems
Cardiovascular · 91d
Cleared Jan 30, 1978
TDL-100 B
K772050 · DXY
Pacesetter Systems
Cardiovascular · 91d
Cleared Sep 14, 1977
ADAPTER A-413
K771642 · DTD
Pacesetter Systems
Cardiovascular · 16d
Cleared Sep 14, 1977
UNIVERSAL LEAD ADAPTER, UA-414
K771641 · DTD
Pacesetter Systems
Cardiovascular · 16d
Cleared Dec 23, 1976
LITHIUM IODIDE BATTERY PACEMAKER (#201)
K761143 · DXY
Pacesetter Systems
Cardiovascular · 27d
Cleared Nov 11, 1976
MODEL 100 CARDIAC PACEMAKER
K760757 · DXY
Pacesetter Systems
Cardiovascular · 41d