12 results · 21ms · 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.

NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES

FDA 510(k)
FDA Class 2 ·Neurology

PERICSCOPE, MODEL # PERISC1

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503

FDA 510(k)
FDA Class 2 ·Cardiovascular

PLUM 4-PORT 15 FLTR 2CLV PE LINE 216CM

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·June 27, 2013

RETROFLEX 3 INTRODUCER SHEATH SET

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYB·April 23, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 2, 2011

EPIC PLUS DR

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

BIOLOX OPTION, HEAD, S, 44/-3.0, TAPER 12/14

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code LZO·December 12, 2018

UNKNOWN HIP FEMORAL HEAD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·February 3, 2021

TRI-LOCK BPS SZ 4 HI OFFSET

FDA Adverse Event
Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·November 4, 2015

TRI-LOCK BPS SZ 7 STD OFFSET

FDA Adverse Event
Injury ·1818910 DEPUY ORTHOPAEDICS, INC·Product code KWA·November 4, 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