20 results · 25ms · 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.

PKS OMNI INSTRUMENT

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027

FDA 510(k)
FDA Class 2 ·Cardiovascular

OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE

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

EVOLIS TIBIAL BASE PLATE TI PLASMA SPRAYED

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 14, 2011

ARTICULEZE M HEAD 36MM +5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·December 4, 2013

SUMMIT CEMENTED STEM SZ6 STD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·December 4, 2013

PINN CAN BONE SCREW 6.5MMX30MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code HWC·December 4, 2013

PINNACLE SECTOR II CUP 56MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·December 4, 2013

PINN CAN BONE SCREW 6.5MMX25MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code NDJ·December 4, 2013

PINNACLE MTL INS NEUT36IDX56OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·December 4, 2013

SMARTSET GMV GENTAMICIN 40G

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LOD·December 4, 2013

PINN CAN BONE SCREW 6.5MMX15MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code HWC·December 4, 2013

CEMENTRALIZER 12.0

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·December 4, 2013

SMARTSET GMV GENTAMICIN 40G

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LOD·December 4, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 29, 2013

SECURE II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·April 13, 2011

HOMECHOICE CYCLER-REFURBISHED

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 18, 2008

PVA FOAM EMBOLIZATION PARTICLES

FDA Adverse Event
Malfunction ·COOK INC·Product code KRD·March 26, 2018

SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

FDA Enforcement
Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

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