13 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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DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES WITH SKIN-CARE INGREDIENTS (VITAMIN A, VITAMIN B, OC-LIPOIC ACID, EUCAL
FDA 510(k)
FDA Class 1
·General Hospital
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120234901·Carbide, round, rosehead, fast cutting and low ...
OPUS ROD FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CEMENTED CALCAR HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
UNK MAMMARY IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·October 16, 2024
PINN CAN BONE SCREW 6.5MMX15MM
FDA Adverse Event
Injury
·3006356043 JOHNSON & JOHNSON MEDICAL (DEPUY - SUZH·Product code NDJ·March 27, 2013
2600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 1, 2011
GUIDANT VASOVIEW 7 ENDOSCOPIC VESSEL HARVESTING SYSTEM
FDA Adverse Event
Malfunction
·GUIDANT CARDIAC SURGERY·Product code GCJ·April 2, 2008
COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·August 13, 2018
ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code DHA·January 7, 2012
Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR 892.1000, Regulatory Class II, Product Code 90-LNH and was cleared with K032490
FDA Recall
Terminated
·Toshiba American Med Sys Inc·Product code LNH·October 12, 2005
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