15 results
·
28ms
·
Sources: EU EUDAMED, US FDA
SELITHERM, MODEL C100
FDA 510(k)
FDA Class 2
·Physical Medicine
100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I
FDA 510(k)
FDA Class 2
·Anesthesiology
SARSTEDT NEEDLE PROTECTOR
FDA 510(k)
FDA Class 2
·General Hospital
ERBE
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code GEI·November 2, 2022
MEDTRONIC INFUSE BONE GRAFT DEVICE (RHBMP-2)
FDA Adverse Event
MEDTRONIC, INC.·Product code NEK·March 28, 2013
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·March 7, 2011
PKG STRL EVD SYSTEM (RAD)-NEW
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES, PR·Product code JXG·April 16, 2008
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
ERBE
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code GEI·March 8, 2023
ERBE
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code GEI·February 18, 2025
ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYD
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DQX·May 29, 2009
ERBE
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code GEI·July 27, 2022
BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·February 20, 2025
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
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