17 results
·
27ms
·
Sources: EU EUDAMED, US FDA
CREATINE KINASE TEST (CK) ITEM NUMBER 65411
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Brigade
FDA UDI
Nuvasive, Inc.·00887517961464·Brigade Lateral Trial, 11x34x24mm 15°
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515228962·Pick,3mm point ang 90deg, med, 6 3/8"
PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8
FDA 510(k)
FDA Class 2
·General Hospital
STICK
FDA 510(k)
FDA Class 2
·Dental
STEM: AMISTEM H HA COATED STD STEM SIZE 1
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 12, 2019
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·June 30, 2014
DURALOC 100 SERIES 54MM OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·November 16, 2010
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 14, 2012
HF-RESECTION ELECTRODE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023
STEM: AMISTEM H COATED STD STEM SIZE 1
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 19, 2019
HF-RESECTION ELECTRODE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023
HF-RESECTION ELECTRODE, LOOP, 22.5 FR., 0.35 WIRE, 12°
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code KNS·August 11, 2016
UNKNOWN
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code KNS·October 21, 2022
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
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015