11 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Klarity Bolus
FDA 510(k)
FDA Class 2
·Radiology
WalkMed®
FDA UDI
WALKMED TECHNOLOGIES, LLC·00859695006015·Pump Tubing Set for WalkMed Infusion Pump, 152 cm
Sklar®
FDA UDI
SKLAR CORPORATION·10649111181481·OLSEN HEGAR NH DEL SERR 4 3/4"
REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCU-CHEK SPIRIT
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·October 17, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 2, 2013
INJECTOR LOCKING N40-O
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code ONB·May 13, 2024
ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·July 19, 2017
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