19 results
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22ms
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Sources: EU EUDAMED, US FDA
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814756·GENUMEDI EXTRA WIDE SAND SIZE VII
POSEY BED
FDA 510(k)
FDA Class 1
·General Hospital
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814800·GENUMEDI EXTRA WIDE SILVER SIZE VII
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964079153·The ENDO CARRY-ON Procedure Kit contains all of...
EXTREME MICRO MOSQUITO FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896053601·EXTREME MICRO MOSQUITO FORCEPS EXTREMELY DELICA...
K2M General Instruments
FDA UDI
VB Spine LLC·10888857520370·Split Tube Retractor, Size Ø14x90 mm
GLO-SPEC
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PATTERN RESIN
FDA 510(k)
FDA Class 2
·Dental
AGX
FDA UDI
Widex A/S·05706069748253·Audigy AGXWU-FM (Summer gold S-110 ) RC coil
AGX
FDA UDI
Widex A/S·05706069749106·Audigy AGXWU-FP (Summer gold S-110 ) Telecoil, ...
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 19, 2014
UNKNOWN ZIMMER KNEE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·May 24, 2011
Colonoscope, Model Number CF-H180AL.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 6, 2024
Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
FDA Enforcement
Class II
·Terminated·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·June 12, 2019
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
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Hemodialysis Delivery System, Software Version 2.x.
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·November 17, 2021
Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·March 4, 2015