14 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.

SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033449035·

X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

FDA 510(k)
FDA Class 1 ·General Hospital

MINITUB MULTI-PURPOSE CASSETTES

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

TERUMO TCM II COOLING AND HEATING SYSTEM

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DWC·March 1, 2013

ACCU-CHEK SPIRIT COMBO

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·March 4, 2011

SILICONE ADVANCED OPTIC LENS

FDA Adverse Event
Injury ·BAUSCH & LOMB·Product code HQL·March 13, 2008

DISC HUM 4X100MM RT FLANGED C

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDC·August 15, 2012

DISC CONDYLE KIT W/ HEXALOBULA

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDC·August 15, 2012

DISC ULNA 4X75MM RT W/BRNG C

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWT·August 15, 2012

RICKHAM RESERVOIR

FDA Adverse Event
Injury ·JOHNSON AND JOHNSON PROFESSIONAL, INC. / MEDOS S.A·Product code JXG·November 20, 2015

VENT RES TR RICKHAM LG BA

FDA Adverse Event
Injury ·CODMAN & SHURTLEFF, INC.·Product code JXG·May 15, 2015

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