19 results · 22ms · 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.

ROOT ZX II

FDA 510(k)
FDA Class 1 ·Dental

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197175135·Antrum Curette oval Fig. 1 7mm, 2...

Arthrex®

FDA UDI
ARTHREX, INC.·00888867462052·Dilator, 7.1 x 190mm

SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM)

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

POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE

FDA 510(k)
FDA Class 1 ·General Hospital

LINEAR ST

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 16, 2022

DILATOR, 4.1 X 220MM

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code HNW·October 29, 2024

DILATOR, 6.0 X 200MM

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code HNW·December 2, 2024

DILATOR, 6.0 X 200MM

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code HNW·October 29, 2024

DILATOR, 7.1 X 190MM

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code HNW·October 29, 2024

DILATOR, 7.1 X 190MM

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code HNW·November 26, 2024

DILATOR, 5.1 X 210MM

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code HNW·December 2, 2024

DILATOR, 5.1 X 210MM

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code HNW·October 29, 2024

DILATOR, 4.1 X 220MM

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code HNW·December 2, 2024

Gold-Tite Hexed Retaining Screw 3mm Item: GSH30 Dental implants

FDA Enforcement
Class II ·Terminated·Biomet 3i, LLC·August 24, 2016

DORADO PTA BALLOON DILATATION CATHETER

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·April 8, 2013

SPRINT QUATTRO SECURE S

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 27, 2011

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 10, 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