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"
25–48 of 96
Search insights Median review: 60d Cleared: 100% Top manufacturer: Pacesetter Systems Lead specialty: Cardiovascular
Cleared Mar 07, 1986
PHOENIX MODELS 250/251 PULSE GENERATORS
K855081 · DXY
Pacesetter Systems
Cardiovascular · 78d
Cleared Jan 07, 1986
PROGRAMALITH III MODELS 238 & 239
K854195 · DXY
Pacesetter Systems
Cardiovascular · 84d
Cleared Dec 04, 1985
PACESETTER SYSTEMS ENDOCARDIAL SMALL FIN LEAD
K854405 · DTB
Pacesetter Systems
Cardiovascular · 33d
Cleared Dec 04, 1985
PACESETTER SYSEMS ENDOCARDIAL TRI-FIX LEAD
K854220 · DTB
Pacesetter Systems
Cardiovascular · 47d
Cleared Dec 03, 1985
PACESETTER SYS FAST PASS ENDOCARDIAL LEAD 856 INLI
K853914 · DTB
Pacesetter Systems
Cardiovascular · 71d
Cleared May 21, 1985
PACESETTER SYSTEMS, MODEL 458 ADAPTER SLEEVE
K851665 · DTD
Pacesetter Systems
Cardiovascular · 29d
Cleared May 16, 1985
PROGRAMALITH III MODEL 249 PULSE GENERATOR
K851861 · DXY
Pacesetter Systems
Cardiovascular · 20d
Cleared May 15, 1985
PROGRAMALITH III 240 PULSE GENERATOR
K850464 · DXY
Pacesetter Systems
Cardiovascular · 97d
Cleared Apr 19, 1985
PACESETTER SYSTEMS INC. ENDOCARDIAL FINNED LEAD
K851145 · DTD
Pacesetter Systems
Cardiovascular · 29d
Cleared Apr 10, 1985
PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD
K850652 · DTD
Pacesetter Systems
Cardiovascular · 50d
Cleared Apr 01, 1985
PROGRAMALITH III-3 MODEL 231 PULSE GENERATOR
K850651 · DXY
Pacesetter Systems
Cardiovascular · 41d
Cleared Mar 06, 1985
PACESETTER SYS, ENDOCARDIAL, VENTRICULAR, BIPOLAR
K850576 · DTD
Pacesetter Systems
Cardiovascular · 21d
Cleared Feb 14, 1985
PACESETTER SYSTEMS, INC. ENDOCARDIAL SCREW-IN LEAD
K844857 · DTD
Pacesetter Systems
Cardiovascular · 62d
Cleared Jan 22, 1985
MINIMED EXTERNAL INFUSION PUMP FOR DIAGETICS 504
K844851 · FRN
Pacesetter Systems
General Hospital · 40d
Cleared Jan 22, 1985
MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A
K844792 · FRN
Pacesetter Systems
General Hospital · 43d
Cleared Jan 10, 1985
VIVALITH II 301 PULSE GENERATOR
K844334 · DXY
Pacesetter Systems
Cardiovascular · 64d
Cleared Jan 08, 1985
PERMATHANE 865 & 867 UNIPOLAR POLYURETH
K843703 · DTD
Pacesetter Systems
Cardiovascular · 109d
Cleared Aug 03, 1984
FASTPASS IMPLANTABLE ENDOCARDIAL PAC
K841885 · DTD
Pacesetter Systems
Cardiovascular · 88d
Cleared Aug 03, 1984
MODEL 866 PERMATHANE BIPOLAR, COAXIAL
K841739 · DTD
Pacesetter Systems
Cardiovascular · 98d
Cleared Mar 12, 1984
PACING ELECTRODE
K834431 · DTB
Pacesetter Systems
Cardiovascular · 87d
Cleared Dec 21, 1983
VASCUTEK VASCULAR PROTHESIS VP1200K/50K
K830016 · DSY
Pacesetter Systems
Cardiovascular · 352d
Cleared Dec 16, 1983
PACEMAKER SYS ANALYZER #384
K833647 · KRE
Pacesetter Systems
Cardiovascular · 60d
Cleared Dec 01, 1983
ENDOCARDIAL SCREW-IN LEAD 859 & 861
K833824 · DTB
Pacesetter Systems
Cardiovascular · 31d
Cleared Oct 20, 1983
PERMANTHANE #866 BIPOLAR COAXIAL
K832987 · DTB
Pacesetter Systems
Cardiovascular · 49d