30 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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SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA
FDA 510(k)
FDA Class 2
·Ophthalmic
Bur PM2-70 80K diam Ø3.1 St
FDA UDI
Bien-Air Surgery SA·17630055515824·
Preat
FDA UDI
Preat Corporation·00842092108079·Preci Ball Ti Threaded Female
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317300393·
Ultra-Pro e™ Variable Angle Needle Guide
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436102206·Sterile needle guide with (14 x 91.5cm) telesco...
QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ACULUX, MODEL AX3001, AX3002
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GYNECARE MESH UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTM·May 2, 2018
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·January 25, 2022
BD PYXIS¿ MEDBANK TOWER AUX
FDA Adverse Event
Malfunction
·CAREFUSION 303, INC.·Product code BRY·March 9, 2026
IO-FLEX
FDA Adverse Event
Malfunction
·BAXANO, INC.·Product code HAE·December 23, 2013
UNIFY CRT-D
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 9, 2013
QUANTUM MAVERICK BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·May 24, 2011
ELOX EX 53-BP
FDA Adverse Event
Injury
·BIOTRONIK, GMBH AND CO.·Product code DTB·August 5, 2008
AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
FDA Enforcement
Class I
·Terminated·Ventlab Corporation·November 7, 2012
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological
FDA Enforcement
Class II
·Ongoing·GE Healthcare·March 11, 2026
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
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025