21 results · 24ms · Sources: EU EUDAMED, US FDA

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MEDILED MINI

FDA 510(k)
FDA Class 2 ·General Hospital

EVOLUTION LIGHT

FDA UDI
BLV Licht- und Vakuumtechnik GmbH·B5331037350·

Best Medical International

FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365116735·

Custom Procedure Kit

FDA UDI
MEDIVATORS INC.·00677964109751·The ENDO CARRY-ON Procedure Kit contains all of...

Endo Carry-On Procedure Kit

FDA UDI
MEDIVATORS INC.·00677964078859·Endo Carry-On Procedure Kit

Endo Carry-On Procedure Kit

FDA UDI
MEDIVATORS INC.·00677964094774·Endo Carry-On Procedure Kit

Endo Carry-On Procedure Kit

FDA UDI
MEDIVATORS INC.·00677964078972·Endo Carry-On Procedure Kit

BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR

FDA 510(k)
FDA Class 2 ·Orthopedic

POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

FDA 510(k)
FDA Class 1 ·General Hospital

DELTAXSFT10 2MM X 6CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·February 11, 2022

TAPERLOC COMPLETE

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·October 1, 2025

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2013

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·September 19, 2014

XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code NIQ·May 26, 2011

TAPERLOC COMPLETE

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·November 5, 2025

The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

FDA Enforcement
Class II ·Terminated·Baxter Healthcare Corporation·March 10, 2021

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

VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Hemodialysis Delivery System, Software Version 2.x.

FDA Enforcement
Class II ·Ongoing·Baxter Healthcare Corporation·November 17, 2021