12 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.

LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE

FDA 510(k)
FDA Class 2 ·General Hospital

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

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

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033576·Baltic Denture System BDLoad BDLoad Lm6 PLSEbi...

INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MOR2000, PCP, THC

FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918001020·INSTANT-VIEW Multi-Drugs of Abuse Urine Test AM...

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

ACQSIM CT SCANNER

FDA Adverse Event
Malfunction ·PHILIPS·Product code JAK·August 12, 2014

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code PAH·April 3, 2013

BAKRI TAMPONADE BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK UROLOGICAL INC·Product code KNA·February 9, 2011

MBT CEM TIBIAL TRAY SZ2.5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code NJL·April 23, 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

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024