21 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GELSOFT PLUS ERS
FDA 510(k)
FDA Class 2
·Cardiovascular
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950012749·IV ARMBOARD BLACK FOR 1040 ADEC CHAIR
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091034010·Baltic Denture System BDLoad BDLoad Mn7 PLSEbi...
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR289300340101·Mand. 1. Molar bands Dura-Fit right 34
STILLE Uterine Curettes
FDA UDI
Stille AB·07332339205966·UTERINE CURETTE RECAMIER STILLE malleable sharp...
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR289200340101·Mand. 1. Molar bands Dura-Fit left 34
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR288300340101·Max. 1. Molar band Dura-Fit right 34
InSePtion MIS Fixation System
FDA UDI
Kalitec Direct LLC·B07314K0140100·Set Screw Driver Shaft, Final Torque, T15
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR288200340101·Max. 1. Molar band Dura-Fit left 34
K034020
FDA Adverse Event
Injury
·C.R. BARD, INC. (BASD)·Product code LJS·November 16, 2007
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710820340100·Zadik Calcaneal Guide, 34mm x 10°
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710610340100·Tri-Channel Met-Traverse, 34mm x 10mm
INTRACRANIAL PRESSURE MONITORING KIT
FDA Adverse Event
Malfunction
·INTEGRA NEUROCARE LLC·Product code GWM·October 24, 2002
ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
466FXXXX
FDA Adverse Event
Injury
·CORDIS CASHEL·Product code DTK·November 19, 2018
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·April 3, 2013
ASR UNI FEMORAL IMPL SIZE 55
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 17, 2011
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 24, 2008
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