14 results
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24ms
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Sources: EU EUDAMED, US FDA
RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-310F; JUGULAR/SUBCLAVAIN DELIVERY KIT, MODEL RF-320J
FDA 510(k)
FDA Class 2
·Cardiovascular
Matira
FDA UDI
Kalitec Direct LLC·B073K0730000·Plate Bender, Universal
ALPHATEC
FDA Adverse Event
ALPHATEC MFG INC. AKA NEXMED INC·Product code HWC·February 26, 2004
SOPRO 67D OPERATING ROOM CAMERA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM
FDA 510(k)
FDA Class 1
·Dental
STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code JDQ·April 23, 2013
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·April 29, 2011
RIATA ST OPTIM PASSIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01
FDA Enforcement
Class II
·Ongoing·Biomerieux Inc·January 11, 2023
UNKNOWN HIP COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·January 29, 2025
VANGUARD SSK FEMORAL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 6, 2019
VANGUARD (TM) DCM TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 6, 2019
OSS TIBIAL POLY BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·January 13, 2025
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