26 results
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12ms
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Sources: EU EUDAMED, US FDA
Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S
FDA Recall
Open, Classified
·EMPATICA SRL Via Enrico Stendhal·Product code POS·July 13, 2023
Ambu VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000)
FDA Recall
Open, Classified
·Ambu Inc.·Product code CBI·September 16, 2024
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code CBH·November 18, 2024
HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code CBH·November 18, 2024
HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code CBH·November 18, 2024
Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
FDA Recall
Open, Classified
·Ambu Inc.·Product code CBI·June 3, 2022
AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,
FDA Recall
Open, Classified
·Hollister Incorporated·Product code CBH·December 23, 2024
AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,
FDA Recall
Open, Classified
·Hollister Incorporated·Product code CBH·December 23, 2024
AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,
FDA Recall
Open, Classified
·Hollister Incorporated·Product code CBH·December 23, 2024
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code CBH·November 18, 2024
AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,
FDA Recall
Open, Classified
·Hollister Incorporated·Product code CBH·December 23, 2024
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
FDA Recall
Open, Classified
·ROi CPS LLC·Product code OEZ·September 21, 2023
Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. regard Item Number: 880396007, NU01001G - Craniotomy ; 4. regard Item: 880387005, NU00991E - Ant/Cervical Spine ; and 5. regard Item Number: 800716005, NU00921E - ORMC Major Crani Pack.
FDA Recall
Open, Classified
·ROi CPS LLC·Product code OJG·March 22, 2023
Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
FDA Recall
Open, Classified
·ROi CPS LLC·Product code OHM·March 22, 2023
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
FDA Recall
Open, Classified
·ROi CPS LLC·Product code MLS·December 26, 2024
Regard, Item Number 830067009, custom cardiovascular procedure kit
FDA Recall
Open, Classified
·ROi CPS LLC·Product code OEZ·March 4, 2021
Regard Kit containing the Microtek decanter
FDA Recall
Open, Classified
·ROi CPS LLC·Product code KPE·June 17, 2024
regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
FDA Recall
Open, Classified
·ROi CPS LLC·Product code OEQ·July 24, 2024
Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.
FDA Recall
Open, Classified
·ROi CPS LLC·Product code MLS·March 22, 2023
Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item Number: 800725004, GS00930D - OH Base Robot Pack ; 4. regard Item Number: 800725005, GS00930E - OH Base Robot Pack ; 5. regard Item Number: 800395003, GS01000C - Colon Lithotomy and 6. regard Item Number: 880391002, GS00995B - Basic Laparotomy.
FDA Recall
Open, Classified
·ROi CPS LLC·Product code LRO·March 22, 2023