19 results · 38ms · 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.

SERIM DISINTEK GTA 2.1%, MODEL: 5164

FDA 510(k)
FDA Class 2 ·General Hospital

NOBELACTIVE INTERNAL RP 4.3X8.5MM

FDA Adverse Event
Injury ·NOBEL BIOCARE AB·Product code DZE·August 17, 2020

NOBELACTIVE INTERNAL NP 3.5X8.5MM

FDA Adverse Event
Injury ·NOBEL BIOCARE AB·Product code DZE·September 9, 2020

NOBELACTIVE INTERNAL NP 3.5X8.5MM

FDA Adverse Event
Injury ·NOBEL BIOCARE AB·Product code DZE·September 9, 2020

NOBELACTIVE INTERNAL RP 4.3X8.5MM

FDA Adverse Event
Injury ·NOBEL BIOCARE AB·Product code DZE·August 17, 2020

BILOX PROSTHESIS HEAD 12/14 28MM L

FDA Adverse Event
Malfunction ·AESCULAP AG AND CO. KG·Product code LWJ·May 23, 2014

TIMX SPINAL SYSTEMS

FDA 510(k)
FDA Class 2 ·Orthopedic

BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN

FDA 510(k)
FDA Class 2 ·Dental

BIOLOX PROSTHESIS HEAD 12/14 28MM S

FDA Adverse Event
Malfunction ·AESCULAP AG & CO. KG·Product code LWJ·April 27, 2012

BIOLOX PROSTHESIS HEAD 12/14 28MM S

FDA Adverse Event
Malfunction ·AESCULAP AG & CO. KG·Product code LWJ·April 14, 2014

BIOLOX PROSTHESIS HEAD 12/14 28MM M

FDA Adverse Event
Malfunction ·AESCULAP AG & CO. KG·Product code LWJ·April 27, 2012

BIOLOX PROSTHESIS HEAD 12/14 32MM L

FDA Adverse Event
Malfunction ·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014

BIOLOX PROSTHESIS HEAD 12/14 28MM S

FDA Adverse Event
Malfunction ·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 29, 2013

PROTECTIV PLUS

FDA Adverse Event
Malfunction ·SMITHS MEDICAL·Product code FOZ·May 3, 2011

ENDO CATH II 15MM SPECIMEN POUCH

FDA Adverse Event
Injury ·SANTO DOMINGO - USS·Product code GCJ·July 28, 2008

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024