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

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ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE

FDA 510(k)
FDA Class 2 ·Cardiovascular

ASAHI CONFIANZA PRO 8-20

FDA Adverse Event
Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·August 23, 2016

ASAHI CONFIANZA PRO 8-20

FDA Adverse Event
Injury ·ASAHI INTECC CO., LTD.·Product code DQX·April 14, 2016

ASAHI CONFIANZA PRO 8-20

FDA Adverse Event
Injury ·ASAHI INTECC CO., LTD.·Product code DQX·June 6, 2016

Schroeder Vulsellum Bone Clamp

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896116566·Schroeder Vulsellum Bone Clamp With Speed Lock ...

Oph. Cystotomes

FDA UDI
KATENA PRODUCTS, INC.·00841668113677·CYSTOTOME STRAIGHT 27GA

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172971185·

AUTOSTAT II ENA-4 PROFILE ELISA

FDA 510(k)
FDA Class 2 ·Immunology

BIOCUFF,C, MODELS 236018, 236028, 236036

FDA 510(k)
FDA Class 2 ·Orthopedic

STAPLE, IMPLANTABLE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 9, 2013

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·September 19, 2014

SLEEVE 5MM DIAM.,WITH THREAD

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INSTRUMENTS·Product code HET·May 25, 2011

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·June 16, 2011

PATIENT INFORMATION CENTER IX

FDA Adverse Event
Injury ·PHILIPS MEDICAL SYSTEMS·Product code MHX·December 4, 2023

Infant Warmer System (IWS)

FDA Enforcement
Class II ·Terminated·GE Healthcare, LLC·January 18, 2017

Infant Warmer System (IWS)

FDA Enforcement
Class II ·Terminated·GE Healthcare, LLC·June 21, 2017

BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021