452 results
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8ms
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Sources: EU EUDAMED, US FDA
Cirugia Cardiovascular Case Cart, c ode 900-1415A, contains: (1) CIRUGIA CARDIOVASCULAR .(INDUCCION) (1) CIRUGIA CARDIOVASCULAR (CIRUGIA ) (1) CIRUGIA CARDIOVASCULAR (PREP ENFERMERA CIRCULANTE) (1) CIRUGIA CARDIOVASCULAR (PERFUSION SUPPLIES) (1) CIRUGIA CARDIOVASCULAR (POST- CIRUGIA) (1) OPEN HEART TRAY Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code 5-10313 3) HVT 7.0 mm, Product Code 5-10314 4) HVT 7.5 mm, Product Code 5-10315 5) HVT 8.0 mm, Product Code 5-10316 6) HVT 8.5 mm, Product Code 5-10317 Product Usage: Tracheal tube/airway management
FDA Enforcement
Class I
·Terminated·Teleflex Medical·June 26, 2019
Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product Code 5-22513 3) EZ-ENDO 7.0 mm, Product Code 5-22514 4) EZ-ENDO 7.5 mm, Product Code 5-22515 5) EZ-ENDO 8.0 mm, Product Code 5-22516 6) EZ-ENDO 8.5 mm, Product Code 5-22517 Product Usage: Tracheal tube/airway management
FDA Enforcement
Class I
·Terminated·Teleflex Medical·June 26, 2019
DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue to provide better visualization access.
FDA Enforcement
Class I
·Terminated·Carefusion 2200 Inc·August 3, 2016
Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213 3) CF 7.0 mm, Product Codes: 5-10114, 5-10214 4) CF 7.5 mm, Product Codes: V5-10115, 5-10115, 5-10215 5) CF 8.0 mm, Product Codes: 5-10116, 5-10216, V5-10116 6) CF 8.5 mm, Product Codes: 5-10117, 5-10217 Product Usage: Tracheal tube/airway management
FDA Enforcement
Class I
·Terminated·Teleflex Medical·June 26, 2019
Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm, Product Code V5-10315 3) Novaplus 8.0 mm, Product Code V5-10316 4) Novaplus 8.5 mm, Product Code V5-10317 Product Usage: Tracheal tube/airway management
FDA Enforcement
Class I
·Terminated·Teleflex Medical·June 26, 2019
Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b) 5-22312, c) 5-22112, d) 5-22012, 2) Preformed 6.5 mm, Product Codes: a) 5-22313, b) 5-22213, c) 5-22013, d) 5-22113, 3) Preformed 7.0 mm, Product Codes: a) 5-22214, b) 5-22314, c) 5-22014, d) 5-22114, 4) Preformed 7.5 mm, Product Codes: a) 5-22215, b) 5-22315, 5) Preformed 8.0 mm, Product Codes: a) 5-22216, b) 5-22316, 6) Preformed 8.5 mm, Product Codes: 5-22217 Product Usage: Tracheal tube/airway management
FDA Enforcement
Class I
·Terminated·Teleflex Medical·June 26, 2019
Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6.5 mm, Product Code 5-10413 3) Uncuffed 7.0 mm, Product Code 5-10414 Product Usage: Tracheal tube/airway management
FDA Enforcement
Class I
·Terminated·Teleflex Medical·June 26, 2019
Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product code 1504032. VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile. VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.
FDA Enforcement
Class I
·Terminated·Synovis Surgical Innovations, Inc.·June 10, 2015
ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: The ADVOCATE¿ Redi-Code+ BMB-BA006A Blood Glucose test strips are used only with the ADVOCATE¿ Redi-Code+ BMB-EA004S meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf, and the thigh.
FDA Enforcement
Class I
·Terminated·DIABETIC SUPPLY OF SUNCOAST, INC.·July 30, 2014
Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.
FDA Enforcement
Class I
·Terminated·Centurion Medical Products Corporation·August 7, 2019
ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A
FDA Enforcement
Class I
·Terminated·Ethicon Endo-Surgery Inc·November 6, 2019
Centurion Convenience Kits, containing BD Alaris Pump Infusion Sets. BD code 11522558 (Centurion code 110931) contained inside kits DYNJ52509A and DYNJ52510A. Product Usage: The Centurion Primary Set Pack and Primary Warmer Pack Convenience Kit helps continuously or intermittently deliver fluids, medications, blood and blood products to adult, pediatric or neonatal patients.
FDA Enforcement
Class I
·Terminated·Medline Industries Inc·August 21, 2019
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A
FDA Enforcement
Class I
·Terminated·Ethicon Endo-Surgery Inc·November 6, 2019
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A
FDA Enforcement
Class I
·Terminated·Ethicon Endo-Surgery Inc·November 6, 2019
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A
FDA Enforcement
Class I
·Terminated·Ethicon Endo-Surgery Inc·November 6, 2019
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400
FDA Enforcement
Class I
·Terminated·Arrow International Inc·July 8, 2020
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500
FDA Enforcement
Class I
·Terminated·Arrow International Inc·July 8, 2020
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0400E
FDA Enforcement
Class I
·Terminated·Arrow International Inc·July 8, 2020
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I
FDA Enforcement
Class I
·Terminated·Arrow International Inc·July 8, 2020