10 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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RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04
FDA 510(k)
FDA Class 1
·Ophthalmic
Mul-T-Pad
FDA UDI
STRYKER CORPORATION·07613327261325·
Mul-T-Pad
FDA UDI
C2DX, INC.·10850007350090·Temperature Therapy Pad
CLEARMEDICAL/NOVAMEDIX AVI FOOT COVER, PAIR, REGULAR & LARGE SIZE
FDA 510(k)
FDA Class 2
·Cardiovascular
BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 18, 2013
V-LOC 90 ABS CLOS DEVICE 3-0 CL 18 P-12
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GAM·April 8, 2011
HCPII ACETABULAR COMPONENT LONGEVITY CROSSLINKED POLYETHYLENE LINER STANDARD
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KWB·June 18, 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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015