24 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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