81 results · 13ms · Sources: EU EUDAMED, US FDA

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Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·January 27, 2025

OxyMask O2 Adult REF OM-1125-14

FDA Recall
Open, Classified ·Southmedic, Inc.·Product code CCK·May 25, 2021

Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL

FDA Recall
Open, Classified ·Product code GCJ·February 28, 2024

Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT

FDA Recall
Open, Classified ·Product code GCJ·February 28, 2024

Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL

FDA Recall
Open, Classified ·Product code GCJ·February 28, 2024

Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT

FDA Recall
Open, Classified ·Product code GCJ·February 28, 2024

Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL

FDA Recall
Open, Classified ·Product code GCJ·February 28, 2024

Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z

FDA Recall
Open, Classified ·Maquet Cardiovascular, LLC·Product code MWS·October 16, 2024

Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS

FDA Recall
Open, Classified ·Product code GCJ·February 28, 2024

Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB

FDA Recall
Open, Classified ·Product code GCJ·February 28, 2024

Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z

FDA Recall
Open, Classified ·Maquet Cardiovascular, LLC·Product code MWS·October 16, 2024

INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, Model Number: 10007

FDA Recall
Open, Classified ·Mallinckrodt, LLC.·Product code MRN·June 23, 2022

ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.

FDA Recall
Open, Classified ·Maquet Cardiovascular, LLC·Product code DWS·June 28, 2023

ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.

FDA Recall
Open, Classified ·Maquet Cardiovascular, LLC·Product code DWS·June 28, 2023

ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.

FDA Recall
Open, Classified ·Maquet Cardiovascular, LLC·Product code DWS·June 28, 2023

Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z

FDA Recall
Open, Classified ·Maquet Cardiovascular, LLC·Product code MWS·September 13, 2023

Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500

FDA Recall
Open, Classified ·SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain·Product code IZL·August 12, 2022

Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.

FDA Recall
Open, Classified ·Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France·Product code PHX·April 10, 2025

SOZO Bilateral Arm L-Dex Software

FDA Recall
Open, Classified ·Product code OBH·August 17, 2023

Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI; 4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ; 5) CATH LAB PACK , Pack Number 00-398725AM; 6) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399360K ; 7) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399734N ; 8) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983Q ; 9) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983R ; 10) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400065K ; 11) ANGIO PROCEDURE PACK, Pack Number 00-400069F ; 12) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AC; 13) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AD; 14) ANGIO PROCEDURE PACK, Pack Number 00-400290D ; 15) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400305Q ; 16) MOUNT SINAI HOSPITAL-ANGIO PK , Pack Number 00-400763F ; 17) ANGIOGRAPHY DRAPE PACK-LF , Pack Number 00-400863J ; 18) ANGIOGRAPHY DRAPE , Pack Number 00-400932O ; 19) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401030S ; 20) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401178D ; 21) ANGIO PROCEDURE PACK, Pack Number 00-401189I ; 22) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401226K ; 23) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318L ; 24) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318M ; 25) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327Y ; 26) CORONARY ANGIO PACK-LF, Pack Number 00-401594Q ; 27) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401620J ; 28) ANGIO PROCEDURE PACK, Pack Number 00-401824AA; 29) CATH LAB PACK-LF, Pack Number 00-HCT055P ; 30) CATH ACCESSORY PACK , Pack Number 0M-CP31433G; 31) CATH ACCESSORY PACK , Pack Number 0M-CP31433I; 32) ANGIO PACK, Pack Number 0M-CP31933C; 33) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357I; 34) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357J; 35) ANTERIOR CERVICAL CDS-LF, Pack Number CDS982292D ; 36) CABG 1, Pack Number CDS983663J ; 37) CATH CDS, Pack Number CDS984141I ; 38) ENDO AAA, Pack Number CDS984264I ; 39) ANGIOGRAPHY OR, Pack Number CDS984944C ; 40) ACCESS CATHETER , Pack Number CDS985507F ; 41) ARTHROSCOPY SHOULDER, Pack Number CDS985509F ; 42) SYMPHONY 5FR CATHETER KIT , Pack Number CTK-5K ; 43) SYMPHONY MAX 6FR CATHETER KIT , Pack Number CTK-6K ; 44) NEURO ANGIO PACK, Pack Number DYNDA1431A; 45) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0048560A ; 46) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429L ; 47) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429N ; 48) ANGIO TRAY-LF , Pack Number DYNJ0131200P ; 49) ANGIOGRAM , Pack Number DYNJ0149444J ; 50) ANGIOGRAM , Pack Number DYNJ0149444K ; 51) ANGIOGRAM , Pack Number DYNJ0149444M ; 52) EP LAB DEVICE PACK-LF , Pack Number DYNJ0160556D ; 53) PED CATH PROCEDURE CHILD PK-LF, Pack Number DYNJ0161241F ; 54) no name , Pack Number DYNJ0161241F ; 55) ANGIO PACK-LF , Pack Number DYNJ0165039M ; 56) ANGIO PACK-LF , Pack Number DYNJ0165039N ; 57) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AF; 58) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AG; 59) VASCULAR ANGIO PACK-LF, Pack Number DYNJ0201109AG; 60) ANGIOGRAPHY TRAY-LF , Pack Number DYNJ0220880V ; 61) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0241256L ; 62) ANGIO PACK-LF , Pack Number DYNJ0281048I ; 63) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0290716L ; 64) ANGIO PROCEDURE PACK-LF , Pack Number DYNJ0298504AG; 65) ANGIOGRAPHIC PACK-LF, Pack Number DYNJ0337491C ; 66) ARTERIOGRAM PACK-LF , Pack Number DYNJ0362293D ; 67) CATH LAB PACK-LF, Pack Number DYNJ0362352M ; 68) CATH PACK-LF, Pack Number DYNJ0367643Q ; 69) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0370415I ; 70) CATH LAB PACK-LF, Pack Number DYNJ0371696O ; 71) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0372025G ; 72) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098K ; 73) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098L ; 74) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098M ; 75) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OEQ·April 8, 2024