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

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GIRAFFE INCUBATOR

FDA 510(k)
FDA Class 2 ·General Hospital

Endeavour™ TruColor™

FDA UDI
METREX RESEARCH, LLC·00615375013601·Endeavour™ TruColor™ headlight system - North A...

PHYSICA FIXED TIBIAL PLATE #2

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A.·Product code JWH·March 8, 2023

DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

POROCOAT PRODIGY HIP PROSTHESIS

FDA 510(k)
FDA Class 2 ·Orthopedic

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·May 9, 2013

9600

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 10, 2011

SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

FDA Adverse Event
Injury ·STAAR SURGICAL CO.·Product code HQL·August 5, 2008

FUSION 8MM-40CM UNSUPP PERIPHERAL GRAFT

FDA Adverse Event
Malfunction ·MAQUET CV·Product code DSY·February 8, 2017

ACCUFILL BSM 3CC

FDA Adverse Event
Injury ·ETEX CORPORATION·Product code MQV·October 30, 2020

REAL INTELLIGENCE ROBOTIC DRILL

FDA Adverse Event
Malfunction ·BLUE BELT TECHNOLOGIES·Product code OLO·February 5, 2026

REAL INTELLIGENCE ROBOTIC DRILL

FDA Adverse Event
Malfunction ·BLUE BELT TECHNOLOGIES·Product code OLO·February 9, 2026

Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·June 12, 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

Model Number U128, VALITUDE CRT-P EL MRI

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

VALITUDE CRT-P pacemaker, Models: a) U125 b) U128

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

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

INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

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

ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

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