1,819 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775I; 2) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775J; 3) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775K; 4) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775L; 5) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775M; 6) TONSIL PACK, Medline Kit Number/SKU DYNJ84480; 7) VITRECTOMY, Medline Kit Number/SKU DYNJVB1080; 8) VITRECTOMY, Medline Kit Number/SKU DYNJVB1080A.
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·June 24, 2026
VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·September 24, 2025
Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests.
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·September 24, 2025
Medline procedural kits labeled as: 1) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417 ; 2) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417A; 3) DRAWER 9L , Pack Number ACC010427A; 4) MEDICATION DELIVERY MODULE, Pack Number ACC010605 ; 5) DRAWER 3, Pack Number ACC010641 ; 6) NEONATAL DRAWER 6 , Pack Number ACC010653 ; 7) DRAWER 2, Pack Number ACC010690 ; 8) ****, Pack Number ACC010690 ; 9) DRAWER 3, Pack Number ACC010784 ; 10) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 11) CIRCUMCISION KIT, Pack Number CIT6535; 12) CIRCUMCISION TRAY, Pack Number CIT6720; 13) CIRCUMCISION TRAY, Pack Number CIT6720A; 14) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 15) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 16) CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6925; 17) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095; 18) RETINA LAC/USC PACK , Pack Number CMPJ03205D; 19) AAA PACK-LF, Pack Number CMPJ09869B; 20) ****, Pack Number CMPJ21114P; 21) BRONCHOSCOPY KIT, Pack Number DYKE1764; 22) TRUNK KIT W/OUT EXPIRATION, Pack Number DYKM1360A ; 23) PRE OP KIT, Pack Number DYKS1256B ; 24) CIRCUMCISION TRAY, Pack Number DYNDA2271; 25) DMEK KIT, Pack Number DYNDA3103 ; 26) KIT, NICU - PICU , Pack Number DYNDL1576 ; 27) BASIC EYE PACK-LF , Pack Number DYNJ0413783N ; 28) VASCULAR PACK, Pack Number DYNJ34240I; 29) VASCULAR PACK-LF, Pack Number DYNJ52214 ; 30) SONDHEIMER, Pack Number DYNJ53853C; 31) BUCKLE PACK, Pack Number DYNJ57439A; 32) RETINA CUSTOM PACK, Pack Number DYNJ57970A; 33) AESC PHACO PACK, Pack Number DYNJ58135C; 34) PED RIGHT LEFT HEART PK MHS , Pack Number DYNJ58874 ; 35) PEDIATRIC RIGHT HEART PK MHS, Pack Number DYNJ58875 ; 36) CV MAJOR, Pack Number DYNJ64530 ; 37) ORL BRONCHOSCOPY PACK, Pack Number DYNJ80103A; 38) ISLET CELL , Pack Number DYNJ80490 ; 39) FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179 ; 40) FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179H; 41) ACCESSORY KIT, Pack Number DYNJ901348D; 42) AAA, Pack Number DYNJ905651B; 43) PROCEDURE TRAY , Pack Number DYNJRA0345F; 44) PROCEDURE TRAY , Pack Number DYNJRA1250B; 45) PROCEDURE TRAY , Pack Number DYNJRA1777; 46) BLOCK TRAY, Pack Number DYNJRA2352; 47) ADULT CORONARY PACK , Pack Number DYNJV0275O; 48) ****, Pack Number DYNJV0275O; 49) NURSING KIT, Pack Number EDUC05026 ; 50) RNSG 2308 , Pack Number EDUC1031; 51) RNSG 2308 , Pack Number EDUC1031H ; 52) RNSG 2201 , Pack Number EDUC1034; 53) RNSG 2201 , Pack Number EDUC1034H ; 54) RETINAL INJECTION KIT, Pack Number MNS12465; 55) ARTHROGRAPH TRAY, Pack Number MNS12670A; 56) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 57) PERIPHERAL ULTRASOUND CATHETER, Pack Number MNS9865 ; 58) UVT KIT , Pack Number PAIN1396; 59) SHUNT PACK-LF, Pack Number PHS967363W; 60) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 61) GLMI ARTHROGRAM KIT , Pack Number SPEC0300B ; 62) UA/UV CATHETERIZATION TRAY, Pack Number UVT1190B; 63) UMBILICAL TRAY , Pack Number UVT1195 ; 64) UVT KIT , Pack Number UVT1200 ; 65) UVT KIT , Pack Number UVT1200H; 66) UMBILICAL CATH KIT, Pack Number UVT1210 ; 67) UMBILICAL VESSEL TRAY W/O CATH, Pack Number UVT150; 68) UMBILICAL VESSEL CATHETER TRAY, Pack Number UVT665A ; 69) UMBILICAL VESSEL TRAY W/O CATH, Pack Number UVT915
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024
Medline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100; 2) LAVH CDS, Pack Number CDS760049AD; 3) LAVH CDS, Pack Number CDS760049AF; 4) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056G ; 5) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088Q ; 6) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088R ; 7) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088S ; 8) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186P ; 9) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186R ; 10) LAVH CDS, Pack Number CDS920130K ; 11) LAVH PROCEDURE, Pack Number CDS980754R ; 12) LAVH PROCEDURE, Pack Number CDS980754S ; 13) VAG HYST KIT, Pack Number CDS981313L ; 14) VAG HYST KIT, Pack Number CDS981313M ; 15) MINOR LITHOTOMY , Pack Number CDS982037W ; 16) MAJOR LITHOTOMY , Pack Number CDS982052V ; 17) D&C CDS , Pack Number CDS982061K ; 18) LAVH, Pack Number CDS982273Q ; 19) LAVH, Pack Number CDS982273R ; 20) LAVH, Pack Number CDS982273S ; 21) BAP NORTH BASIC MINOR GYN CDS , Pack Number CDS982397C ; 22) D&C HYSTEROSCOPY CDS-LF , Pack Number CDS982602K ; 23) GYN LAP HYSTERECTOMY CDS, Pack Number CDS982662P ; 24) GYN LAP HYSTERECTOMY CDS, Pack Number CDS982662Q ; 25) ABDOMINAL HYSTERECTOMY CDS SJF, Pack Number CDS982669N ; 26) GYN LITHOTOMY CDS SJF-LF, Pack Number CDS982679M ; 27) VAGINAL MAJOR , Pack Number CDS982689S ; 28) VAGINAL MAJOR , Pack Number CDS982689T ; 29) GYN/ABDOMINAL , Pack Number CDS982725K ; 30) GYN/ABDOMINAL , Pack Number CDS982725N ; 31) MAG MAJOR VAGINAL CDS , Pack Number CDS982907J ; 32) MAG MAJOR VAGINAL CDS , Pack Number CDS982907M ; 33) VAG HYST/SLING CDS-3, Pack Number CDS983006D ; 34) TOTAL LAPHYSTERECTOMY CDS , Pack Number CDS983055J ; 35) TOTAL LAPHYSTERECTOMY CDS , Pack Number CDS983055K ; 36) CUH LITHOTOMY CDS , Pack Number CDS983207M ; 37) CUH LITHOTOMY CDS , Pack Number CDS983207N ; 38) VAGINAL MINOR , Pack Number CDS983268I ; 39) LAVH CDS, Pack Number CDS983411I ; 40) LAVH CDS, Pack Number CDS983411J ; 41) LAVH CDS, Pack Number CDS983411K ; 42) LAVH PROCEDURE, Pack Number CDS983449L ; 43) LAVH PROCEDURE, Pack Number CDS983449M ; 44) LAVH PROCEDURE, Pack Number CDS983449N ; 45) LAVH CDS, Pack Number CDS983455C ; 46) MAJOR VAGINAL , Pack Number CDS983497J ; 47) MAJOR VAGINAL , Pack Number CDS983497L ; 48) LAPAROTOMY GYN CDS, Pack Number CDS983529M ; 49) VAG HYST CDS, Pack Number CDS983697J ; 50) GYN LITHOTOMY MAJOR LAC CDS , Pack Number CDS983780I ; 51) GYN MAJOR ABDOMINAL LAC CDS , Pack Number CDS983803K ; 52) GYN MINOR CDS , Pack Number CDS983985G ; 53) GYN ABDOMINAL CDS , Pack Number CDS983988A ; 54) MAJOR GYN LAPAROSCOPY CDS , Pack Number CDS984007C ; 55) TVT CDS , Pack Number CDS984091J ; 56) GROTH VAGINAL CDS , Pack Number CDS984201T ; 57) NHP Abdominal Hyst CDS, Pack Number CDS984234J ; 58) GYN CDS , Pack Number CDS984676C ; 59) TSH VAG HYSTERECTOMY CDS, Pack Number CDS985304; 60) TSH VAG HYSTERECTOMY CDS, Pack Number CDS985304A ; 61) DAVINCI HYSTERECTOMY CDS, Pack Number CDS985344F ; 62) HYSTEROSCOPY/D&C, Pack Number CDS985522G ; 63) MAJOR & MINOR LITHOTOMY , Pack Number CDS985525J ; 64) MAJOR LITHOTOMY , Pack Number CDS985547N ; 65) PROCEDURE TRAY, Pack Number DYNDA2966; 66) PERI-GYN PACK-LF, Pack Number DYNJ0038057A ; 67) TVH TRAY, Pack Number DYNJ00460L ; 68) TVH TRAY, Pack Number DYNJ00460M ; 69) D&C HYSTEROSCOPY PACK-LF, Pack Number DYNJ0046646F ; 70) D&C HYSTEROSCOPY PACK-LF, Pack Number DYNJ0046646G ; 71) LAVH PACK-LF, Pack Number DYNJ00470K ; 72) LAVH PACK-LF, Pack Number DYNJ00470L ; 73) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D ; 74) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768F ; 75) VAG. HYST TRAY-LF , Pack Number DYNJ0209066N ; 76) PERI GYN PACK-LF, Pack Number DYNJ0362432P ; 77) LAVH PACK-LF, Pack Number DYNJ0372824Q ; 78) VAGINAL HYSTERECTOMY PACK-LF, Pack Number DYNJ0373807I ; 79) VAGINAL HYSTERECTOMY PACK-LF, Pack Number DYNJ0373807J ; 80) VAGINAL HYSTERECTOMY PACK-
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024
Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the Power Module, the Mobile Power Unit, Lithium-Ion Batteries, or its own integrated emergency backup supply, down to the LVAD via the Driveline. The HeartMate 3 System Controller constantly monitors system performance through communication with the implanted LVAD and Controller internal measurements and alerts the user to any alarm conditions by activating membrane panel LEDs and integrated audio annunciators. Further information on alarm conditions as well as system status can be attained by the user from the front panel LCD on the System Controller. When connected to a HeartMate Touch" Communication System, the System Controller sends information regarding the System Controller and Pump Status once per second to provide additional information to the user. This link also allows the clinician to set new patient operating parameters (e.g. pump speed) and provides a link for downloading trend and/or event recorder data. Component: Yes, HeartMate 3 Left Ventricular System (LVAS) Kits
FDA Enforcement
Class II
·Ongoing·Thoratec LLC·June 24, 2026
Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Description: The HeartMate 11 Volt Lithium Ion Standalone Backup Battery is a component of the HeartMate 3" System Controller and provides power to the System Controller. The HeartMate System Controller is an external device that manages the HeartMate Left Ventricular Assist System (LVAS), including alarms, system monitoring, and communication. It contains an internal 11V lithium-ion backup battery that provides at least 15 minutes of emergency power should the main system power source fail. The backup battery must be properly installed, charges automatically during normal use, and has a 36-month service life from date of manufacture. Component: Yes, HeartMate 3" System Controller
FDA Enforcement
Class II
·Ongoing·Thoratec LLC·June 24, 2026
Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050
FDA Enforcement
Class II
·Ongoing·Covidien LLC·June 10, 2026
Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044
FDA Enforcement
Class II
·Ongoing·Covidien LLC·June 10, 2026
Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042
FDA Enforcement
Class II
·Ongoing·Covidien LLC·June 10, 2026
COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable inner cannulae (LPC, FEN, CFS, CFN, LGT) and twist-lock connectors. These Shiley Tracheostomy Tubes have a radiopaque, biocompatible outer cannula constructed of polyvinyl chloride.
FDA Enforcement
Class II
·Ongoing·Covidien LLC·June 10, 2026
Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No Product Description: 11-9099 - ICEMAN, W/COLDPAD, NS, RH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No
FDA Enforcement
Class II
·Ongoing·DJO, LLC·May 20, 2026
Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product Description: 11-0494 - ICEMAN CLASSIC CUBE The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: no
FDA Enforcement
Class II
·Ongoing·DJO, LLC·May 20, 2026
Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Product Description: 11-1422 - ICEMAN W/,UNIV,LOOP,NS,RH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No
FDA Enforcement
Class II
·Ongoing·DJO, LLC·May 20, 2026
Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Product Description: 11-1424 - ICEMAN W/,UNIV,LOOP,NS,EH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No
FDA Enforcement
Class II
·Ongoing·DJO, LLC·May 20, 2026
Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
FDA Enforcement
Class II
·Ongoing·Gentuity, LLC·April 22, 2026
PIE Trolley System Model: 2005
FDA Enforcement
Class II
·Ongoing·Edermy LLC·March 4, 2026
PIE PAK Models: P2HC-A, P2HC-S, P2HC
FDA Enforcement
Class II
·Ongoing·Edermy LLC·March 4, 2026
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS).
FDA Enforcement
Class II
·Ongoing·Covidien LLC·March 18, 2026
CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System for ECMO, REF: CMAEK01. CentriMag Blood Pump is a component to be used with CentriMag Acute Circulatory Support System
FDA Enforcement
Class II
·Ongoing·Thoratec LLC·January 21, 2026