20 results
·
19ms
·
Sources: EU EUDAMED, US FDA
PEPTONE YEAST EXTRACT GLUCOSE BROTH
FDA 510(k)
FDA Class 1
·Microbiology
Signature III
FDA UDI
Rmo, Inc.·00885797101662·SIG III ROTH .018, 20 BRKT KIT
CLYDESDALE SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PFC SIGMA LUGGED TIBIAL TRAY
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
Zimmer, Inc.·00889024132931·
NA
FDA UDI
Zimmer, Inc.·00889024132962·
NA
FDA UDI
Zimmer, Inc.·00889024132924·
NA
FDA UDI
Zimmer, Inc.·00889024132948·
NA
FDA UDI
Zimmer, Inc.·00889024132955·
PLATE CDC ANAEROBE 5% SB 100 EA JP
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·September 9, 2021
PLATE CDC ANAEROBE 5% SB 20 EA
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JSG·June 28, 2021
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 21, 2024
LEGEND FOOTED ATTACHMENT
FDA Adverse Event
Injury
·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·May 9, 2014
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code LDD·October 24, 2012
ABBOTT LIFECARE PCA PUMP PLUS 2 MODEL
FDA Adverse Event
Malfunction
·ABBOTT·Product code MEA·August 12, 2010
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MAX·December 18, 2019
PLATE CDC ANAEROBE AGAR 5% SB 90MM 20
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSG·February 17, 2022
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code OJA·June 11, 2024
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
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018