206 results
·
14ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
×
Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / QS6-BXXCS: b) QS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX: c) QS6 AM12Q KIT Z200 BCRT IEC / QS-6CC-DFCXX: d) QS6 AM12Q RS SYS AHA XML / QS-6JB-AXAXA: e) QS6 AM12Q SYS Z200 PCRT AHA XML / QS6-BLXCX: f) QS6 AM12Q TMX SYS Z200 PCRT AHA XML / QS6-BLXC1: g) QS6 AM12Q TTL KIT AHA / QS-6AC-XXAXX: h) QS6 AM12Q TTL KIT AHA / QS-6AC-XXBXX: i) QS6 AM12Q TTL KIT AHA XML / QS-6AC-XXAXA: j) QS6 AM12Q TTL KIT AHA DICOM / QS6-AXTDS: k) QS6 AM12Q TTL KIT AHA XML / QS-6AC-AXAAA: l) QS6 AM12Q TTL KIT AHA XML / QS-6AC-XXBXA: m) QS6 AM12Q TTL KIT AHA XML / QS-6AC-CXBXA: n) QS6 AM12Q TTL KIT AHA XML / QS-6AC-DXAXA: o) QS6 AM12Q TTL KIT AHA XML / QS6-MXTCS: p) QS6 AM12Q TTL KIT BCRT AHA DICOM / QS-6AC-CGAAB: q) QS6 AM12Q TTL KIT Z200 AHA XML / QS-6AC-XAAXA: r) QS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-EEBXX: s) QS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DFAAX: t) QS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DEAAX: u) QS6 AM12Q TTL KIT Z200 BCRT AHA DICOM / QS-6AC-CFBAB: v) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-CFBAA: w) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-DFBAA: x) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-CFAAA: y) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-DFAAA: z) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CECAA: aa) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-AFCXA: bb) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CFEAA: cc) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CFCAA: dd) QS6 AM12Q TTL KIT Z200 PCRT AHA DICOM / QS-6AC-ACAAB: ee) QS6 AM12Q TTL KIT Z200 PCRT AHA DICOM / QS-6AC-DDBAB: ff) QS6 AM12Q TTL KIT Z200 PCRT AHA SVR / QS-6AC-DDBAC: gg) QS6 AM12Q TTL KIT Z200 PCRT AHA XML / QS-6AC-CDBXA: hh) QS6 AM12Q TTL KIT Z200 PCRT AHA XML / QS-6AC-DDBAA: ii) QS6 AM12Q TTL SYS AHA XML / QS-6AB-BXAXA: jj) QS6 AM12Q TTL SYS BCRT AHA DICOM / QS-6AB-CGAAB: kk) QS6 AM12Q TTL SYS Z200 BCRT AHA / QS-6AA-DEAXX: ll) QS6 AM12Q TTL SYS Z200 BCRT AHA XML / QS-6AB-CEAAA: mm) QS6 AM12Q TTL SYS Z200 BCRT AHA XML / QS-6AD-AEAAA: nn) QS6 AM12Q TTL SYS Z200 PCRT AHA / QS-6AD-BCAAX: oo) QS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS-6AA-ACAAB: pp) QS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS-6AA-DDAAB: qq) QS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS6-ATTDX: rr) QS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS-6AA-XCAAA: ss) QS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS6-MLTCX: tt) QS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS6-MTTCX: uu) QS6 AM12Q TTL SYS Z200 PCRT IEC XML / QS-6AA-CDCAA: vv) QS6 AM12Q TTL SYS Z200 PCRT IEC XML / QS-6AA-DDCAA: ww) QS6 AM12Q TTL TMX KIT BCRT AHA XML / QS-6BC-CGAAA: xx) QS6 AM12Q TTL TMX KIT Z200 PCRT IEC XML / QS-6BC-CDCXA: yy) QS6 AM12Q TTL TMX SYS Z200 BCRT AHA DIC / QS-6BB-CFAAB: zz) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS-6BD-ACAAB: aaa) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS-6BA-ACAAB: bbb) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS6-ATTD1: ccc) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-ACAAA: ddd) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-DDDAA: eee) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-ACBAA: fff) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS6-MLTC1: ggg) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS6-MTTC1: hhh) QS6 AM12QKIT AHA XML / QS-6CC-XXAXA: iii) QS6 AM12QKIT AHA / QS-6CC-XXBXX: jjj) QS6 AM12QKIT BCRT AHA DICOM / QS-6CC-XGAAB: kkk) QS6 AM12QKIT BCRT IEC / QS-6CC-DGCAX: lll) QS6 AM12QKIT Z200 AHA / QS-6CC-XAAXX: mmm) QS6 AM12QKIT Z200 BCRT IEC / QS-6CC-DFCAX: nnn) QS6 AM12QSYS BCRT IEC XML / QS-6CA-DGCAA: ooo) QS6 AM12QSYS IEC XML / QS-6CB-CXCXA: ppp) QS6 AM12QSYS Z200 BCRT IEC / QS-6CB-DFCAX: qqq) QS6 AM12QSYS Z200 BCRT IEC XML / QS-6CA-DFCAA: rrr) QS6 NOACQMOD KIT NO LDSET XML / QS-6XC-XXXXA: sss) QS6 NOACQMOD KIT NO LDSET / QS-6XC-BXXXX: ttt) QS6 NOACQMOD KIT NO LDSET DICOM / QS-6XC-XXXXB: uuu) QS6 NOACQMOD SYS Z200 BCRT NO LDSET XML / QS-6XA-DFXAA: vvv) QS6 PRO ENHANCED SECURITY / QS6-STTDX: www)
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·January 17, 2024
XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX; b) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-DXXXX; c) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-XXXXX; d) XS6 WAM TTL KIT IEC XML BRAZIL, XSCRIBE-5AX-XXBRZ; e) XS6 WAM TTL SYS Z200 AHA XML, XSCRIBE-6AA-AAAAA; f) XS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AA-ADBXX; g) XS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-AFAAA; h) XS6 WAM TTL SYS Z200 PCRT AHA SVR, XSCRIBE-6AA-AFAAC; i) XS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-AFAXA; j) XS6 WAM TTL SYS Z200 PCRT AHA DICOM, XSCRIBE-6AA-AFAXB; k) XS6 WAM TTL SYS Z200 BCRT AHA DICOM, XSCRIBE-6AA-BCAAB; l) XS6 WAM TTL SYS AHA XML, XSCRIBE-6AA-BXAAA; m) XS6 WAM TTL SYS AHA DICOM, XSCRIBE-6AA-BXAAB; n) XS6 WAM TTL SYS AHA, XSCRIBE-6AA-BXAXX; o) XS6 WAM TTL SYS Z200 BCRT IEC XML, XSCRIBE-6AA-CDBAA; p) XS6 WAM TTL SYS Z200 BCRT IEC DICOM, XSCRIBE-6AA-CDBAB; q) XS6 WAM TTL SYS Z200 BCRT IEC SVR, XSCRIBE-6AA-CDBAC; r) XS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AA-CDBAX; s) XS6 WAM TTL SYS BCRT AHA DICOM, XSCRIBE-6AA-CEAAB; t) XS6 WAM TTL SYS BCRT IEC DICOM, XSCRIBE-6AA-CEBAB; u) XS6 WAM TTLSYS Z200 BCRT IEC DICOM, XSCRIBE-6AA-DDBAB; v) XS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-DGAAA; w) XS6 WAM TTL SYS Z200 PCRT IEC DICOM, XSCRIBE-6AA-DGBAB; x) XS6 WAM TTL SYS Z200 PCRT IEC, XSCRIBE-6AA-DGBAX; y) XS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-XFAAA; z) XS6 WAM TTL SYS Z200 PCRT AHA DICOM, XSCRIBE-6AA-XFAAB; aa) XS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-XFAXA; bb) XS6 WAM TTL SYS Z200 PCRT IEC XML, XSCRIBE-6AA-XFBXA; cc) XS6 WAM TTL SYS BCRT AHA, XSCRIBE-6AB-BEAXX; dd) XS6 WAM TTL SYS AHA XML, XSCRIBE-6AB-BXAXA; ee) XS6 WAM TTL SYS Z200 BCRT AHA XML, XSCRIBE-6AB-CDAAA; ff) XS6 WAM TTL SYS Z200 BCRT AHA DICOM, XSCRIBE-6AB-CDAAB; gg) XS6 WAM TTLSYS Z200 BCRT IEC DICOM, XSCRIBE-6AB-CDBAA; hh) XS6 WAM TTL SYS Z200 BCRT IEC DICOM, XSCRIBE-6AB-CDBAB; ii) XS6 WAM TTL SYS Z200 BCRT IEC SVR, XSCRIBE-6AB-CDBAC; jj) XS6 WAM TTL SYS BCRT AHA XML, XSCRIBE-6AB-CEAAA; kk) XS6 WAM TTL SYS BCRT IEC, XSCRIBE-6AB-CEBAX; ll) XS6 WAM TTL SYS Z200 BCRT IEC DICOM, XSCRIBE-6AB-DDBAB; mm) XS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AB-DDBAX; nn) XS6 WAM TTL SYS BCRT IEC XML, XSCRIBE-6AB-DEBAA; oo) XS6 WAM TTL SYS BCRT IEC DICOM, XSCRIBE-6AB-DEBAB; pp) XS6 WAM TTL SYS BCRT IEC SVR, XSCRIBE-6AB-DEBAC; qq) XS6 WAM TTL SYS AHA XML, XSCRIBE-6AB-DXAAA; rr) XS6 WAM TTL SYS AHA XML, XSCRIBE-6AB-DXAXA; ss) XS6 WAM TTLSYS Z200 BCRT AHA XML, XSCRIBE-6AB-XCAAA; tt) XS6 WAM TTLKIT Z200 AHA DICOM, XSCRIBE-6AC-AAAAB; uu) XS6 WAM TTL KIT Z200 AHA, XSCRIBE-6AC-AAAAX; vv) XS6 WAM TTL KIT Z200 AHA, XSCRIBE-6AC-AAAXX; ww) XS6 WAM TTL KIT Z200 BCRT AHA, XSCRIBE-6AC-ACAAX; xx) XS6 WAM TTL KIT Z200 BCRT AHA, XSCRIBE-6AC-ACAXX; yy) XS6 WAM TTL KIT BCRT AHA XML, XSCRIBE-6AC-AEAAA; zz) XS6 WAM TTL KIT BCRT AHA, XSCRIBE-6AC-AEAXX; aaa) XS6 WAM TTL KIT AHA XML, XSCRIBE-6AC-AXAAA; bbb) XS6 WAM TTL KIT AHA XML, XSCRIBE-6AC-AXAXA; ccc) XS6 WAM TTL KIT AHA, XSCRIBE-6AC-AXAXX; ddd) XS6 WAM TTL KIT Z200 BCRT AHA DICOM, XSCRIBE-6AC-BDAAB; eee) XS6 WAM TTL KIT BCRT AHA SVR, XSCRIBE-6AC-BEAAC; fff) XS6 WAM TTL KIT BCRT AHA, XSCRIBE-6AC-BEAXX; ggg) XS6 WAM TTL KIT AHA XML, XSCRIBE-6AC-BXAXA; hhh) XS6 WAM TTL KIT AHA, XSCRIBE-6AC-BXAXX; iii) XS6 WAM TTL KIT Z200 BCRT IEC XML, XSCRIBE-6AC-CDBAA; jjj) XS6 WAM TTL KIT Z200 BCRT IEC DICOM, XSCRIBE-6AC-CDBAB; kkk) XS6 WAM TTL KIT BCRT IEC, XSCRIBE-6AC-CEBAX; lll) XS6 WAM TTL KIT IEC XML, XSCRIBE-6AC-CXBAA; mmm) XS6 WAM TTL KIT IEC DICOM, XSCRIBE-6AC-CXBAB; nnn) XS6 WAM TTL KIT Z200 IEC XML, XSCRIBE-6AC-DBBXA; ooo) XS6 WAM TTL KIT Z200 BCRT IEC XML, XSCRIBE-6AC-DCBXA; ppp) XS6 WAM TTL KIT Z200 BCRT IEC XML, XSCRIBE-6AC-DDBAA; qqq) XS6 WAM TTL KIT Z200 BCRT IEC DICOM, XSCRIBE-6AC-DDBAB; rrr) XS6 WAM TTL KIT Z200 BCRT IEC DICOM, XSCRIBE-6AC-DDBXB; sss) XS6 WAM TTL KIT BCRT IEC XML, XSCRIBE-6AC-DEBAA; ttt) XS6 WAM TTL KIT BCRT IEC
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·January 17, 2024
LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). The cprCOACHTM Feedback Technology in the LIFEPAK CR2 defibrillator is indicated for use on cardiopulmonary arrest patients and provides CPR guidance in accordance with the AHA Guidelines for patients 1 year of age or older. The LIFEPAK CR2 defibrillator is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support/AED, advanced life support, or a physician-authorized emergency medical response training program.
FDA Enforcement
Class II
·Ongoing·Physio-Control, Inc.·September 10, 2025
Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069D 3) CAMPUS EXTREMITY PK, Model Number: DYNJ51935A 4) FOOT -XRAY BOWL MEDCUP SPECCUP, Model Number: DYNJ68902A 5) RADIOLOGY SPINE PACK, Model Number: DYNJ80679A 6) DR CHA CUSTOM PACK, Model Number: DYNJ82370A 7) SPINE PACK HC, Model Number: DYNJ84272
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·April 29, 2026
ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring, and for CPR monitoring of patients. The CPR monitoring function provides a metronome designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of at least 2 inches (5 cm) for adult patients. The AED PRO system is indicated for use on victims of cardiac arrest with apparent lack of circulation as indicated by: Unconsciousness Absence of breathing, and Absence of pulse and other signs of circulation. The device is also indicated for use when ECG monitoring is indicated to evaluate the patient s heart rate or ECG morphology. The AED PRO system is indicated for adult and pediatric patients.
FDA Enforcement
Class II
·Ongoing·ZOLL Medical Corporation·July 10, 2019
ORAcollect RNA: ORE-100
FDA Enforcement
Class II
·Ongoing·DNA Genotek Inc.·April 27, 2022
ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.025
FDA Enforcement
Class II
·Ongoing·DNA Genotek Inc.·April 27, 2022
Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Grey Electric Heating Pad, PE-MtyBls-HeatPad-12x24-Gry-V2
FDA Enforcement
Class I
·Ongoing·Whele LLC DBA Perch·November 30, 2022
AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syringes, Rx, Sterile.
FDA Enforcement
Class II
·Ongoing·MRP, LLC dba Aquabiliti·February 28, 2024
Mighty Bliss Electric Heating Pad, Extra-Large (20 x 24 ) Blue Electric Heating Pad, MB-002
FDA Enforcement
Class I
·Ongoing·Whele LLC DBA Perch·November 30, 2022
Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001
FDA Enforcement
Class I
·Ongoing·Whele LLC DBA Perch·November 30, 2022
Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.
FDA Enforcement
Class II
·Ongoing·Medical Components, Inc dba MedComp·March 17, 2021
NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
FDA Enforcement
Class II
·Ongoing·Orthosoft, Inc. dba Zimmer CAS·March 9, 2022
Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002
FDA Enforcement
Class II
·Ongoing·LUMINOSTICS, INC dba CLIP HEALTH·October 19, 2022
AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD420
FDA Enforcement
Class II
·Ongoing·King Systems Corp. dba Ambu, Inc.·November 6, 2024
KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD432
FDA Enforcement
Class II
·Ongoing·King Systems Corp. dba Ambu, Inc.·November 6, 2024
Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842
FDA Enforcement
Class I
·Ongoing·Mercury Enterprises, Inc. dba Mercury Medical·January 22, 2025
KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD4225
FDA Enforcement
Class II
·Ongoing·King Systems Corp. dba Ambu, Inc.·November 6, 2024
KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD422
FDA Enforcement
Class II
·Ongoing·King Systems Corp. dba Ambu, Inc.·November 6, 2024
KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD421
FDA Enforcement
Class II
·Ongoing·King Systems Corp. dba Ambu, Inc.·November 6, 2024