16 results · 20ms · 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.

CAS-One Liver

FDA 510(k)
FDA Class 2 ·Neurology

LEONE SPA

FDA UDI
LEONE SPA·08033707011828·CALIBRA 1ST MOL BANDS W/G8025-03 n.UL 24

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K1430210·Rod Template, 500mm

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K1430200·Rod Template, 250mm

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A143024150·14mm H x 30mm W x 24mm L x 15 degrees ALIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A14302480·14mm H x 30mm W x 24mm L x 8 degrees ALIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A143024120·14mm H x 30mm W x 24mm L x 12 degrees ALIF

TORQUE DEVICE

FDA 510(k)
FDA Class 2 ·Cardiovascular

RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 6, 2025

HAMILTON-G5

FDA Adverse Event
Malfunction ·HAMILTON MEDICAL AG·Product code CBK·October 24, 2023

GORE TAG THORACIC ENDOPROSTHESIS

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code MIH·May 23, 2013

SYNCHROMED II

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·June 23, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·September 3, 2008

Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL) 1) List Number 43056-01; 2) List Number 43023-01; 3) List Number 43025-01; 4) List Number 43025-11; 5) List Number 43025-21; 6) List Number 43025-25; 7) List Number 43038-05; 8) List Number 43043-01; 9) List Number 43044-01; 10) List Number 43044-11; 11) List Number 43046-01; 12) List Number 43047-01; 13) List Number 43041-01; 14) List Number 43024-01; 15) List Number 43027-01; 16) List Number 43027-14; 17) List Number 43001-01; 18) List Number 43064-01; 19) List Number 43046-05; 20) List Number 43042-11; 21) List Number 43042-01; 22) List Number 43044-05; 23) List Number 43044-15

FDA Enforcement
Class II ·Terminated·Hospira Inc.·August 24, 2016

PKG, MARYLAND FORCEPS, CURVED, P/N 0250080248. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·December 24, 2014