27 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SAVI PREPARATION DEVICE
FDA 510(k)
FDA Class 2
·Radiology
Bur PM2-125 80K steel Ø8.0 St
FDA UDI
Bien-Air Surgery SA·17630055519952·
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257010075·M.3 SOFT OA BRACE, VARUS, RIGHT, XS
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450172445·
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383556095·Gutta Percha Points is used to root canal filin...
eTRAX™ Needle
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436103265·Sterile needle, 14GA x 11cm with (7.6 tapered t...
eTRAX™ Needle
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·00841436103251·Sterile needle, 14GA x 11cm with (7.6 tapered t...
SELF-ADHESIVE ELECTRODES
FDA 510(k)
FDA Class 2
·Neurology
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 1, 2024
WAVEWRITER ALPHA? PRIME 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 3, 2025
7 MM EXTENDED LENGTH ENDOSCOPE
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GCJ·May 3, 2013
CRUTCH
FDA Adverse Event
UNKNOWN·Product code IPR·September 19, 2014
COMPACT EXCHANGE DEVICE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - LARGO·Product code KDJ·May 24, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·December 19, 2013
INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
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
Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module consist of EGG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·March 4, 2015
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012
Model Number L101, ESSENTIO DR SL Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025