14 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.

DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM

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

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033449042·

PRESSURE WIRE SENSOR, MODEL 12003/12303

FDA 510(k)
FDA Class 2 ·Cardiovascular

EMIT II PLUS METHADONE ASSAY, MODEL OSRE229

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

CD HORIZON LEGACY MINI SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS, INC.·Product code MNI·February 3, 2012

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·October 16, 2024

TERUMO TCM II COOLING AND HEATING SYSTEM

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

UNKNOWN DEPUY UNI FEMORAL COMPONENT

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·February 24, 2011

EASY LOAD INSERTER

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

Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012

Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste Management System Instructions For Use. Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012

Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International) Instructions For Use 0700-001-700, 0700-002-707 Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012

Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012