26 results · 33ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

TSRH(R) SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Endeavour™ TruColor™

FDA UDI
METREX RESEARCH, LLC·00615375013540·Endeavour™ TruColor™ headlight system - North A...

Sklar®

FDA UDI
SKLAR CORPORATION·10649111379598·MAYO INSTR HOLDER

Torcon NB

FDA UDI
COOK INCORPORATED·00827002060876·Torcon NB, Advantage Catheter

Torcon NB

FDA UDI
COOK INCORPORATED·00827002470309·Torcon NB Advantage Catheter

LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA

FDA 510(k)
FDA Class 2 ·Ophthalmic

MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL)

FDA 510(k)
FDA Class 2 ·Anesthesiology

ACTIVA PC

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·October 18, 2010

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 29, 2025

DYN-LOCK-SCR Ø5 SELF-TAP L32 COCRMO

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code HWC·May 9, 2013

TERUMO CDI 540 CALIBRATOR

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·May 10, 2011

TALENT THORACIC STENT GRAFT SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·August 7, 2008

CANTATA 2.9 SUPERSELECTIVE MICROCATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code KRA·September 14, 2017

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·November 1, 2018

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·June 15, 2020

IMMULITE® 2000 3GALLERGY SPECIFIC IGE

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·December 11, 2024

IMMULITE 2000 3GALLERGY SPECIFIC IGE UNIVERSAL KIT (SPE)

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·October 1, 2022

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

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 L211 PROPONENT DR SL MRI Pacemaker

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