13 results · 21ms · Sources: EU EUDAMED, US FDA

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VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS, MODEL 00-7840-XXX-XX

FDA 510(k)
FDA Class 2 ·Orthopedic

HairCheck-DT (PCP)

FDA UDI
Quest Diagnostics·00868586000254·HairCheck-DT (PCP) is an ELISA test kit used fo...

JOBST forMen

FDA UDI
BSN MEDICAL, INC.·04042809870046·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND OPEN T...

HARMONIC ACE 36 CM

FDA Adverse Event
Injury ·ETHICON ENDO SURGERY, INC.·Product code LFL·December 12, 2005

MODIFICATION TO PROFILE -II

FDA 510(k)
FDA Unclassified ·Unknown

DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT

FDA 510(k)
FDA Class 2 ·Orthopedic

PROSIMA PELVIC FLOOR REPAIR KIT

FDA Adverse Event
Injury ·ETHICON, INC.·Product code OTP·April 9, 2013

INFANT WARMER HEATER ASSEMBLY

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code FMT·April 6, 2011

VENTAK PRIZM 2 DR

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

EVOLUT FX PLUS VALVE

FDA Adverse Event
Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·March 3, 2025

Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER

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

HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704

FDA Enforcement
Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018