17 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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ZIMMER ORTHO GUIDANCE SYSTEMS- HIP INSTRUMENTS
FDA 510(k)
FDA Class 2
·Neurology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033223·Baltic Denture System BDLoad BDLoad ↓ Mm6 PLSEu...
GEON DIGITAL CLINICAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM (PVOCS)
FDA 510(k)
FDA Class 2
·Anesthesiology
D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·February 27, 2014
D903 DIDECO AVANT 2 VAVD PHISIO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·February 19, 2014
IT PADOVA
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·August 8, 2013
D903 DIDECO AVANT VAVD PHISIO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·August 16, 2013
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 3, 2013
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·February 28, 2011
PT2 GUIDE WIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code DQX·April 16, 2008
C20441 IL HAIFA
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DWF·March 28, 2012
DEPUY ASR XL FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.·Product code KXA·December 18, 2013
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 2023
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024