14 results · 22ms · Sources: EU EUDAMED, US FDA

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SMITH & NEPHEW MIS HIP STEM

FDA 510(k)
FDA Class 2 ·Orthopedic

BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C AND 190D

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

HYGIA HEALTH SERVICE REPROCESSED KENDALL SCD SLEEVE, MODELS # 5329, 5330, 5345, 5480

FDA 510(k)
FDA Class 2 ·Cardiovascular

FAST1 INTRAOSSEOUS INFUSION SYSTEM

FDA Adverse Event
Other ·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009

FAST1 INTRAOSSEOUS INFUSION SYSTEM

FDA Adverse Event
Other ·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 7, 2020

FAST1 INTRAOSSEOUS INFUSION SYSTEM

FDA Adverse Event
Other ·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009

FAST1 INTRAOSSEOUS INFUSION SYSTEM

FDA Adverse Event
Other ·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009

REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HTD·April 23, 2013

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 8, 2011

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 24, 2016

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

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015