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

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Servator P SALF Solution with THAM

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

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112878·CORNEAL TREPHINE BLADE6.5MM

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112465·BARRON VACUUM TREPHINE 6.5MM

ALPHATRAC, MODEL A 205

FDA 510(k)
FDA Class 2 ·Physical Medicine

SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 30, 2025

PRECISION SPECTRA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·June 3, 2025

COBAS C 503 ANALYTICAL UNIT

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·April 2, 2026

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 8, 2011

INSPIRATION LS VENTILATOR SYSTEM

FDA Adverse Event
Malfunction ·EVENT MEDICAL LTD.·Product code CBK·August 8, 2014

S-ROM*STM STD,36NK,16X11X150

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·July 2, 2013

Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·July 10, 2024

CA090, DIRECT DRIVE LCA 3/BX

FDA Adverse Event
Malfunction ·APPLIED MEDICAL RESOURCES·Product code FZP·February 24, 2017

CA090, DIRECT DRIVE LCA 3/BX

FDA Adverse Event
Malfunction ·APPLIED MEDICAL RESOURCES·Product code FZP·February 24, 2017

CA090, DIRECT DRIVE LCA 3/BX

FDA Adverse Event
Malfunction ·APPLIED MEDICAL RESOURCES·Product code FZP·February 24, 2017

HANDPIECE MICS

FDA Adverse Event
Malfunction ·MAKO SURGICAL CORP.·Product code OLO·March 4, 2019

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

FDA Enforcement
Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 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