17 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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BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TOBRAMYCIN (GP) 0.5-16UG/ML
FDA 510(k)
FDA Class 2
·Microbiology
PYRAMESH® C Titanium Mesh
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490484671·PYRAMESH IMPLANT 22MMX50MM RND
PYRAMESH® C Titanium Mesh
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000855819·PYRAMESH IMPLANT 22MMX50MM RND
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192114·Apex Revision Knee Reamer – ZIMMER SHORT FLUTES...
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code FSA·April 25, 2013
Expert
FDA UDI
C A I INDUSTRIES CORP·00807689005315·0.22x50mm acupuncture needles.
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197383257·FOERSTER Sponge Forceps
250mm,...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197532945·Vascular DeBakey Forceps
Ø5mm, ...
FOERSTER SPONGE FORCEPS, 25CM (10”), STRAIGHT, SERRATED
FDA UDI
W.H. Holden, Inc.·D9281500522500·
RAICHEM MULTI-ANALYTE CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200
FDA 510(k)
FDA Class 2
·Cardiovascular
NUVASIVE
FDA Adverse Event
Injury
·NUVASIVE·Product code NKB·January 10, 2011
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 4, 2013
LEAD MODEL UNK
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·May 23, 2008
COATED VICRYL RAPIDE (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Injury
·ETHICON. SAS AUNEAU·Product code GAM·April 12, 2011
DISP.TROCAR THRD.W.DILATING PIN 12/110MM
FDA Adverse Event
Malfunction
·AESCULAP AG·Product code GCJ·July 9, 2019
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