30 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Bur PM2-70 80K diam EC Ø3.5 St
FDA UDI
Bien-Air Surgery SA·17630055519860·
Cradle
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·00841436115124·For use with Mindray 6LB7s Multi-Purpose Workst...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450299562·
MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER
FDA 510(k)
FDA Class 1
·Ophthalmic
GLYCOSAL HBA1C TEST
FDA 510(k)
FDA Class 2
·Hematology
NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·September 5, 2024
NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·September 5, 2024
ALT HA S CLR EXT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code MEH·November 14, 2023
CVC SET: 2-LUMEN 14 FR X 25 CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code MPB·May 3, 2013
SPECTRA OPTIA
FDA Adverse Event
Malfunction
·TERUMO BCT·Product code LKN·September 19, 2014
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·May 24, 2011
NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·May 31, 2024
NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·August 12, 2024
BIOLOX DELTA FEMORAL HEAD 32MM OD, -3.5MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·October 3, 2024
NV GXL LINER LIPPED 36MM ID GROUP 2
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·November 1, 2022
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