13 results
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19ms
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Sources: EU EUDAMED, US FDA
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