17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DARCO LOCKING BONE PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SOAR Retractor System
FDA UDI
SPINEOLOGY INC.·M7603061808·18mm x 80mm Portal Tube
Millennia Software
FDA UDI
BRAEMAR MANUFACTURING, LLC·B146C1MA080·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694017657·MFx Tag, Auto-Drive Angulated Locking Screw, 8mm
DORO HEADREST SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX)
FDA 510(k)
FDA Class 2
·General Hospital
Acapella One
FDA UDI
Choice Spine, LP·00840996151146·ACAPELLA,TRIAL,PA,NS,14X18X8
AUTO ENDO5 ML
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FZP·August 8, 2017
ASKU
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026
ASKU
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026
CLEARLINK CONTINU-FLO SOLUTION SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·December 6, 2021
CADENCE ZOLL PRECONNECT
FDA Adverse Event
Malfunction
·COVIDIEN·Product code MLN·March 29, 2013
PROSTIVA
FDA Adverse Event
Malfunction
·MPROC, VILLALBA·Product code KNS·April 4, 2011
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·June 13, 2008
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024