20 results
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36ms
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Sources: EU EUDAMED, US FDA
ANSPACH LEG SUPPORT
FDA 510(k)
FDA Class 1
·Anesthesiology
NUPRO® Prophylaxis Paste with Fluoride
FDA UDI
DENTSPLY INTERNATIONAL INC.·D0038013301·NUPRO® Prophy Paste, Chocolate Bliss, Medium, S...
ACUMED
FDA UDI
Acumed LLC·10806378048456·Pelvic Plating Screw Caddy, Base
Symmetry Hardy
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482030578·Symmetry® Curette, Hardy, Angled Down, 5 mm Tip...
Chisel
FDA UDI
BICON, LLC·00813110025722·3.0mm Ridge Expanding Chisel
CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)
FDA 510(k)
FDA Class 2
·Anesthesiology
SOVEREIGN BIPOLAR INSTRUMENTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KONG-C VBR M, Body, 30 mm
FDA UDI
icotec AG·07640164849751·KONG-C VBR M, Body, 30 mm
BIPOLAR MACRO FORCEPS D:5/ 310MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO KG·Product code GEI·April 6, 2015
BIPOLAR MARYLAND DISS.FCPS 5MM 310MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO KG·Product code GEI·March 9, 2015
JAW INS.BIP.MARYLAND DISS.FEN.5/310MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·August 29, 2014
JAW INS. BIP.MARYLAND DISS.FEN.5/310MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG.·Product code GEI·January 13, 2015
MARYLAND GSP.FORCEPS FEN.5/310MM HF CON.
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·February 19, 2014
JAW INS.BIP.MARYLAND DISS.FEN.5/310MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·August 13, 2015
FORTIFY VR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·May 8, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 18, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 21, 2007
MARYLAND GSP.FORCEPS FEN.5/310MM HF.CON.
FDA Adverse Event
Malfunction
·AESCULAP, INC.·Product code GEI·August 21, 2015
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
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