11 results · 21ms · 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.

BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496030959·STRONG, SIZE ML, FUMO, MICRO-MASSAGING BERMUDA ...

QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA

FDA 510(k)
FDA Class 2 ·Immunology

CRITERION 60 OR PM 60

FDA 510(k)
FDA Class 2 ·Anesthesiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·January 12, 2026

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 2, 2019

GYNECARE MORCELLEX* TISSUE MORCELLATOR

FDA Adverse Event
Malfunction ·ETHICON, INC.·Product code HET·April 2, 2013

OCTRODE PERCUTANEOUS LEAD

FDA Adverse Event
Injury ·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·March 22, 2011

CVC KIT: 2-LUMEN 7 FR X 20 CM

FDA Adverse Event
Malfunction ·ARROW INTL., INC.·Product code DQO·April 16, 2008

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

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018