15 results · 29ms · Sources: EU EUDAMED, US FDA

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SMART BITEBLOC

FDA 510(k)
FDA Class 2 ·Anesthesiology

JOBST forMen

FDA UDI
BSN MEDICAL, INC.·04042809867367·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND CLOSED...

WRISTWATCH BPM BLOOD PRESSURE MONITOR, MODEL KP-6120

FDA 510(k)
FDA Class 2 ·Cardiovascular

ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 21, 2025

MATRIXNEURO STERILE KIT STD 4

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code JEY·December 19, 2013

TI MATRIXNEURO BURR HOLE COVER24MM

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code JEY·October 28, 2015

MINIMAL ACCESS ATTACHMENT

FDA Adverse Event
Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBE·April 2, 2013

SPRINT FIDELIS

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 6, 2011

CONTAK RENEWAL TR 2

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code NKE·May 8, 2008

MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 1U I/C

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HWC·June 23, 2013

MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C

FDA Adverse Event
Malfunction ·SYNTHES BETTLACH·Product code JEY·August 28, 2015

NCB, DF PLATE, RIGHT, 13 HOLES, 324 MM

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code HRS·June 11, 2018

PKG, GRASPER FORCEPS, SERRATED, P/N 0250080286. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·December 24, 2014

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