26 results
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15ms
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Sources: EU EUDAMED, US FDA
PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050
FDA Enforcement
Class II
·Ongoing·Oculus Technologies of Mexico, S.A. de C.V.·June 10, 2026
Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for temporary collection, transfer, and/or storage of body fluids and solid specimen samples for the purpose of laboratory testing.
FDA Enforcement
Class II
·Terminated·Thermo Fisher Scientific (Monterrey)·June 3, 2020
DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
FDA Enforcement
Class II
·Terminated·DJ Orthopedics de Mexico S.A. de C.V.·May 5, 2021
DONJOY REF:11-0473-9 ULTRASLING PRO AB, UNIVERSAL, Rx ONLY, UDI: (01)00190446683681 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
FDA Enforcement
Class II
·Terminated·DJ Orthopedics de Mexico S.A. de C.V.·May 5, 2021
DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
FDA Enforcement
Class II
·Terminated·DJ Orthopedics de Mexico S.A. de C.V.·May 5, 2021
DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
FDA Enforcement
Class II
·Terminated·DJ Orthopedics de Mexico S.A. de C.V.·May 5, 2021
30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
FDA Enforcement
Class II
·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018
20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system.
FDA Enforcement
Class II
·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018
165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
FDA Enforcement
Class II
·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018
DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold, Check Valve, Rotating Luer, Filter Cap is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
FDA Enforcement
Class II
·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018
43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
FDA Enforcement
Class II
·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018
216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, MicroClave Clear, Clamp, Rotating Luer.
FDA Enforcement
Class II
·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018
PROXIMALE - 18 cm (7") Appx 0.92 ml, PUR Smallbore Ext Set, 6-Port NanoClave Manifold w/NanoClave (Purple Rings), Check Valve, Rotating Luer.
FDA Enforcement
Class II
·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018
191 cm (75") Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w/6-Port NanoClave Manifold w/2 Red Rings, Check Valve, 2 MicroClave Clear, Clamp, Rotating Luer.
FDA Enforcement
Class II
·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018
11" Smallbore Ext Set w/NanoClave, 6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer.
FDA Enforcement
Class II
·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018
Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear
FDA Enforcement
Class II
·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018
40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
FDA Enforcement
Class II
·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018
10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow, Green Rings), NanoClave (Light Blue Ring), Check Valve, Clamp, Rotating Luer.
FDA Enforcement
Class II
·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018
28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer.
FDA Enforcement
Class II
·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018
18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer.
FDA Enforcement
Class II
·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018