16 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.

BIOCENTREX CARDIAC PANEL

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033155·Baltic Denture System BDLoad BDLoad ↓ Mm7 PLSEu...

DADE THROMBOPLASTIN C PLUS

FDA 510(k)
FDA Class 2 ·Hematology

VERTEBRAL BODY REPLACEMENT

FDA 510(k)
FDA Class 2 ·Orthopedic

STYLE 68 SALINE FILLED BREAST IMPLANT

FDA Adverse Event
Injury ·ALLERGAN (COSTA RICA)·Product code FWM·August 21, 2024

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·March 1, 2013

840

FDA Adverse Event
Malfunction ·COVIDIEN PURITAN BENNETT·Product code CBK·March 9, 2011

WECK HOL L CLIPS

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code FZP·April 23, 2008

LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL

FDA Adverse Event
Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·February 13, 2018

LARGE EX-FIX 11MM CRBN FBR ROD 250MM / MR-CONDITIONAL

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

LARGE EX-FIX 11MM CRBN FBR ROD 300MM / MR-CONDITIONAL

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

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