21 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED
FDA 510(k)
FDA Class 2
·Orthopedic
PALS Blue
FDA UDI
AXELGAARD MANUFACTURING CO., LTD.·00856817005642·
Mixter Grasping Forceps
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896114043·Mixter Grasping Forceps 45 Degree Angle Double ...
MIXTER GRASPING FORCEP INSERT
FDA UDI
SONTEC INSTRUMENTS, INC.·B09929012400·MIXTER GRASPING FORCEPS ANGLED DOUBLE-ACTION JA...
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889981182724·Reduction Screw Driver, Locking, Square Connect
BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·June 19, 2019
Invenio
FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918194462·Surgical Gown_Set-In sleeve_reinforcement_XXL_N...
TCP
FDA UDI
WRIGHT MEDICAL TECHNOLOGY, INC.·00840420170279·
SERAGARD INJECTION PATCH
FDA 510(k)
FDA Class 1
·General Hospital
ALPHAMED SURGICAL SPEAR, MODEL 70-5000
FDA 510(k)
FDA Class 2
·Ophthalmic
Alleset
FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918160795·Alleset Gown_W/reinforcement_XX-Large_W/ 1 hand...
UNKNOWN
FDA Adverse Event
WILLIAM COOK EUROPE·Product code DTK·October 27, 2015
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·June 30, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 17, 2010
PARIETEX UGYTEX PP POSTERIOR KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·December 10, 2012
BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·May 6, 2019
LOGIC FEMORAL PS CEM LEFT SZ 5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 13, 2023
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
FDA Enforcement
Class I
·Ongoing·Zyno Medical LLC·June 18, 2025
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·April 10, 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