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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

76 results for "Cardiac Pacemakers, Inc."
1–24 of 76
Search insights Median review: 43d Cleared: 100% Top manufacturer: Cardiac Pacemakers, Inc. Lead specialty: Cardiovascular
Cleared Mar 05, 2010
ACUITY BREAK-AWAY GUIDE CATHETER
K093969 · DQY
Cardiac Pacemakers, Inc.
Cardiovascular · 72d
Cleared Mar 20, 2008
ACUITY UNIVERSAL CUTTER
K080154 · DQY
Cardiac Pacemakers, Inc.
Cardiovascular · 57d
Cleared Jan 10, 1994
REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER
K934727 · DWS
Cardiac Pacemakers, Inc.
Cardiovascular · 101d
Cleared Oct 28, 1992
ASTRA T2, ASTRA T4, ASTRA T6
K920601 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 260d
Cleared Jun 17, 1991
PDT CARRYALL TRANSMITTER, VARIOUS MODELS
K912379 · DXH
Cardiac Pacemakers, Inc.
Cardiovascular · 19d
Cleared Jan 30, 1991
LEAD STYLET
K905674 · DRB
Cardiac Pacemakers, Inc.
Cardiovascular · 43d
Cleared Feb 23, 1990
MODIFIED BETATRON IV INSULIN INFUSION SYSTEM
K900498 · LZG
Cardiac Pacemakers, Inc.
General Hospital · 36d
Cleared Sep 13, 1989
MODEL 6888 LEAD TUNNELER
K894738 · DWS
Cardiac Pacemakers, Inc.
Cardiovascular · 48d
Cleared Mar 10, 1989
ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE
K890785 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 23d
Cleared Jan 27, 1988
TORQUE HEX WRENCH
K875147 · DTF
Cardiac Pacemakers, Inc.
Cardiovascular · 43d
Cleared Jan 05, 1988
BETATRON IV SYSTEM
K872774 · FRN
Cardiac Pacemakers, Inc.
General Hospital · 175d
Cleared Feb 19, 1987
ASTRA T2, T4 AND T6
K865013 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 58d
Cleared Dec 05, 1986
ULTRA SOFTWARE MODULE: MODEL 2016
K863046 · KRG
Cardiac Pacemakers, Inc.
Cardiovascular · 115d
Cleared Sep 29, 1986
PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580
K863045 · KRG
Cardiac Pacemakers, Inc.
Cardiovascular · 48d
Cleared Aug 19, 1986
ASTRA 2,3,4 AND 6: CHIP REVISION
K863000
Cardiac Pacemakers, Inc.
Cardiovascular · 11d
Cleared Jul 16, 1986
ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR
K860585 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 148d
Cleared Jun 06, 1986
SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN
K860584 · KRG
Cardiac Pacemakers, Inc.
Cardiovascular · 108d
Cleared Jan 22, 1986
TELEMETRY WAND MODEL
K855171 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 27d
Cleared Jun 07, 1985
INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123
K852060 · FRN
Cardiac Pacemakers, Inc.
General Hospital · 29d
Cleared Oct 17, 1984
ASTRA 2, ASTRA 3, 4 & 6
K842394 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 120d
Cleared Sep 24, 1984
HANDHELD PACEMAKER PROGRAMMER & SOFTWAR
K842364 · KRG
Cardiac Pacemakers, Inc.
Cardiovascular · 98d
Cleared Sep 20, 1984
SENTRA
K843060 · DTD
Cardiac Pacemakers, Inc.
Cardiovascular · 48d
Cleared Nov 28, 1983
BETATRON I AMBULATORY INSULIN PUMP
K833306 · FRN
Cardiac Pacemakers, Inc.
General Hospital · 66d
Cleared Jul 12, 1983
COMMAND ULTRA II
K831216 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 89d