23 results · 19ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.

FDA Enforcement
Class II ·Terminated·Surgical Specialties Mexico S DE RL DE CV·October 19, 2016

MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or ophthalmic surgery.

FDA Enforcement
Class II ·Ongoing·ETHICON, INC.·November 27, 2024

PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050

FDA Enforcement
Class II ·Ongoing·Oculus Technologies of Mexico, S.A. de C.V.·June 10, 2026

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

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

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

61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer, 2 Ext.

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, Check Valve, Clamp, Rotating Luer

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

6" Smallbore Ext Set w/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

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

10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer.

FDA Enforcement
Class II ·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018