13 results · 19ms · Sources: EU EUDAMED, US FDA

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BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN

FDA 510(k)
FDA Class 2 ·Dental

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033815·Baltic Denture System BDLoad BDLoad ↓ Sm6 PLSEu...

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0330150·Coronal Bender, Left

BD¿ 3 ML BD LUER-LOK¿ SYRINGE WITH BLUNT FILL NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 22, 2018

MEDRAD QWIK-FIT SYRINGE

FDA 510(k)
FDA Class 2 ·Cardiovascular

TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER

FDA 510(k)
FDA Class 2 ·Physical Medicine

LAG SCREWS, CROSS-PIN, DIAM.2.0X30MM, (5/PACKAGE)

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS-FREIBURG·Product code JEY·April 3, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED REL·Product code MDS·March 17, 2011

DISTAFLO BYPASS GRAFT

FDA Adverse Event
Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code DSY·April 24, 2008

Speed Stitch Needle Cassette

FDA Enforcement
Class II ·Ongoing·ArthroCare Corporation·September 30, 2020

Cocoon Convective Warming System, Product Code: CWS4000 (110V).

FDA Enforcement
Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020

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