16 results · 29ms · 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.

MOSS MIAMI SPINAL SYSTEMS

FDA 510(k)
FDA Class 2 ·Orthopedic

BETSEY JOHNSON

FDA UDI
FGX INTERNATIONAL INC.·00193033478226·

Navagio

FDA UDI
Kalitec Direct LLC·B07330K0132160·Trial, TLIF, 27L OB CRV 7Deg, 16mm

BETSEY JOHNSON

FDA UDI
FGX INTERNATIONAL INC.·00193033478219·

BETSEY JOHNSON

FDA UDI
FGX INTERNATIONAL INC.·00193033478196·

BETSEY JOHNSON

FDA UDI
FGX INTERNATIONAL INC.·00193033478233·

RADIESSE DERMAL FILLER

FDA Adverse Event
Other ·BIOFORM MEDICAL, INC.·Product code LMH·May 19, 2009

BIOMET SCK KNEE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Injury ·ANIMAS CORPORATION·Product code LZG·March 20, 2013

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 22, 2014

MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

FDA Adverse Event
Malfunction ·MEDTRONIC HEART VALVES, INC·Product code LWR·March 12, 2008

CLS STEM

FDA Adverse Event
Injury ·ZIMMER SWITZERLAND MANUFACTURIN GMBH·Product code KWY·November 25, 2020

UNKNOWN

FDA Adverse Event
Malfunction ·COOK INC·Product code BWC·September 4, 2019

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

Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025