10 results
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17ms
·
Sources: EU EUDAMED, US FDA
COBE/STOCKERT BATTERY MODULE
FDA 510(k)
FDA Class 2
·Cardiovascular
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5828027140·AWL
SURE-SNAP
FDA UDI
Gc Orthodontics America Inc.·E53580271400001·SURE-SNAP 2. MOLAR UPR LFT SZ 14
AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
WARTNER WART REMOVAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 25, 2014
AGC V2 INTERLOK TIB 12X 75MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·October 24, 2012
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 17, 2010
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 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