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"
49–72 of 96
Search insights Median review: 60d Cleared: 100% Top manufacturer: Pacesetter Systems Lead specialty: Cardiovascular
Cleared Sep 12, 1983
INFUSION SETS #'S 124 & 142 PERSONAL
K831445 · FPA
Pacesetter Systems
General Hospital · 130d
Cleared Sep 12, 1983
SINGLE USE SYRINGE #103 PERSONAL MEDIC
K831444 · FRN
Pacesetter Systems
General Hospital · 130d
Cleared Aug 12, 1983
PACELINE PATIENT TRANSMITTER MODEL 324
K831443 · DXH
Pacesetter Systems
Cardiovascular · 99d
Cleared Jun 08, 1983
UNIPOLAR ATRIAL J PACING LEAD MODEL 869
K831436 · DTB
Pacesetter Systems
Cardiovascular · 35d
Cleared Jun 08, 1983
VENTRICULAR PACING LEADS MODELS 865/867
K831435 · DTB
Pacesetter Systems
Cardiovascular · 35d
Cleared Mar 24, 1983
PERSONAL MEDICATION INFUSER
K830570 · FRN
Pacesetter Systems
General Hospital · 30d
Cleared Mar 24, 1983
IMPLANTABLE PACEMAKER PULSE GEN, MODELS 241 & 242
K823878 · DXY
Pacesetter Systems
Cardiovascular · 87d
Cleared Feb 18, 1983
AFP PULSE GENERATOR
K823559 · DXY
Pacesetter Systems
Cardiovascular · 78d
Cleared Feb 18, 1983
AFP SYSTEM PULSE GENERATOR MODEL 261/262
K822639 · DXY
Pacesetter Systems
Cardiovascular · 170d
Cleared Jan 08, 1983
PROGRAMALITH PROGRAMMER
K823242 · KNG
Pacesetter Systems
Obstetrics & Gynecology · 68d
Cleared Dec 30, 1982
ELECTRODE, PACEMAKER, PERMANENT
K823033 · DTB
Pacesetter Systems
Cardiovascular · 77d
Cleared Aug 06, 1982
FASTPASS IMPLANTABLE ENDOCARD. PACING
K821947 · DTB
Pacesetter Systems
Cardiovascular · 37d
Cleared Jun 02, 1982
PACEMAKER 445 ADAPTER
K821549 · DTD
Pacesetter Systems
Cardiovascular · 8d
Cleared Jun 02, 1982
PACEMAKER CONNECTOR PLUG
K821548 · DTD
Pacesetter Systems
Cardiovascular · 8d
Cleared Jun 02, 1982
PACEMAKER UNIPOLAR ADAPTER
K821547 · DTD
Pacesetter Systems
Cardiovascular · 8d
Cleared May 07, 1982
PROGRAMMALITH II, #225 & 226
K821003 · DXY
Pacesetter Systems
Cardiovascular · 28d
Cleared Dec 02, 1981
ADAPTING SLEEVE
K813154 · DTD
Pacesetter Systems
Cardiovascular · 26d
Cleared Dec 02, 1981
TEST MAGNET
K813153 · DTG
Pacesetter Systems
Cardiovascular · 26d
Cleared Dec 02, 1981
ELECTRODE TERMINAL CAP
K813152 · DTD
Pacesetter Systems
Cardiovascular · 26d
Cleared Dec 02, 1981
VITATRON INSERT
K813151 · DTD
Pacesetter Systems
Cardiovascular · 26d
Cleared Dec 02, 1981
DIRECTIONAL BOOT
K813150 · DXY
Pacesetter Systems
Cardiovascular · 26d
Cleared Nov 27, 1981
PACEPATH IMPLANT. ENDOCARD. PACING LEAD
K810286 · DTB
Pacesetter Systems
Cardiovascular · 298d
Cleared Nov 27, 1981
ELECTRODE, PACEMAKER, PERMANENT
K810139 · DTB
Pacesetter Systems
Cardiovascular · 310d
Cleared Nov 06, 1981
PERSONAL MEDICATION INFUSER
K810850 · FRN
Pacesetter Systems
General Hospital · 221d