13 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Reusable Surgical Optical fiber
FDA UDI
QUANTA SYSTEM SPA·08033945937188·Reusable 10X Surgical Optical Fiber ø 200 µm.
D...
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036026615·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100430·Caddie Lid, Adjustable Cross Links
DRG AURICA ELISA TESTOSTERONE KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B
FDA 510(k)
FDA Class 2
·Orthopedic
G7 PPS LTD ACET SHELL 52E
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·February 20, 2019
SPECIAL FOOT PUMP ASSEMBLY
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·March 28, 2018
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 2, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 4, 2011
SIG MOD TIB TRAY CEM COCR 2.5
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC·Product code JWH·July 30, 2008
BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Company·July 27, 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