16 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SURGISIS STAPLE LINE REINFORCEMENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Safco T&F Bur - 12 Bladed
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310220443·Safco T&F bur - 12 bladed, carbide, #7206 taper...
LINK Instruments - Trial implants and size gauges
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575408948·Acetabulum prosthesis trial, reusable - Vario-C...
BD PRECISIONGLIDE NEEDLE 25G X 1 1/2 IN
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·September 20, 2020
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710410220440·Anterior Closing Wedge Osteotomy Guide, 22mm x ...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710420220440·Anterio Lateral Closing Wedge Osteotomy Guide, ...
MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT
FDA 510(k)
FDA Class 2
·Ophthalmic
BI-PHASIC INFILTRATOR
FDA 510(k)
FDA Class 2
·General Hospital
TITAN TOUCH SCRO ZERO ANG 18CM
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code FHW·August 6, 2018
CADD-SOLIS VIP AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC·Product code FRN·January 6, 2025
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·March 26, 2013
SECURE ACUTE CARE BED 3/01
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·March 10, 2011
BD Q SITE EXTENSION SET
FDA Adverse Event
Malfunction
·MPS ACACIA·Product code FPA·March 31, 2008
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 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
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014