17 results
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21ms
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Sources: EU EUDAMED, US FDA
SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Precept
FDA UDI
Nuvasive, Inc.·00887517065216·PRECEPT Handle, Fascial Splitting
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209114405·KIT, ROO K9 HANDLER M-FAK - BASIC - RGR
GLIDESHEATH SLENDER
FDA UDI
TERUMO MEDICAL CORPORATION·00389701012087·GLIDESHEATH SLENDER Stainless Steel Kit
Pliers
FDA UDI
BICON, LLC·00813110029782·Crown Removal Forceps - Posterior
RADIOMED SOURCE
FDA 510(k)
FDA Class 2
·Radiology
INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
STAT DL 9.5 FR. 40 CC. IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·September 16, 1998
FEATHER-FLEX ADULT ANESTHESIA CIRCUIT
FDA Adverse Event
Malfunction
·BOMIMED INC.·Product code BSJ·August 28, 2014
STAT DL 9.5 FR. 40 CC. IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·September 16, 1998
Foot/Ankle General Instrument
FDA UDI
Zimmer, Inc.·00889024068209·
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 8, 2014
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·October 17, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code NBW·September 21, 2007
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
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
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015