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

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DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

NOBELREPLACE CC PMC RP 4.3X10MM

FDA Adverse Event
Injury ·NOBEL BIOCARE USA INC·Product code DZE·June 15, 2021

NOBELPARALLEL CC NP 3.75X13MM

FDA Adverse Event
Injury ·NOBEL BIOCARE AB·Product code DZE·March 8, 2021

NOBELPARALLEL CC NP 3.75X13MM

FDA Adverse Event
Injury ·NOBEL BIOCARE AB·Product code DZE·March 8, 2021

FOCAL SIM

FDA 510(k)
FDA Class 2 ·Radiology

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

2520274-2013-02089

FDA Adverse Event
Injury ·SYNTHES USA·Product code HSB·April 23, 2013

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 29, 2011

RIATA ACTIVE FIXATION LEAD

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000594;

FDA Enforcement
Class II ·Ongoing·Beaver Visitec International, Inc.·September 4, 2024

CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

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

Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024