19 results
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27ms
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Sources: EU EUDAMED, US FDA
UNIVERSAL TEMP. PACING ELECT. #080-10000
FDA 510(k)
FDA Class 2
·Cardiovascular
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551201985·LANGENBECK Retractor, 33 x 14 mm
LF
FDA UDI
Liebel-Flarsheim Company LLC·10746190002208·MR Syringe (2) with Single Check Valve Y-Tubing...
Coverlet®
FDA UDI
BSN MEDICAL, INC.·00035664003401·COVERLET ELASTIC 2" X 3" TAN 50
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209134304·
Symmetry Microvasc®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482031773·Symmetry® Needle Holder, Microvasc, Curved Tip,...
ConneX Cross Connector
FDA UDI
SPINEOLOGY INC.·M7406801800·Cross Connector, Adjustable
Perfect Fit
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377022012·FastTrack Effort Interface Kit
T12S TELEMETRY TRANSMITTER
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCUWARM EMG HEAT LAMP
FDA 510(k)
FDA Class 2
·Physical Medicine
INGEVITY+
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code NVN·December 20, 2024
60/60/90 MULTIPAK-OPTISTAR LE X50
FDA Adverse Event
Malfunction
·SHENZHEN BAOAN MEDICAL SUPPLIES CO., LTD·Product code DXT·January 7, 2021
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HLTHCARE CORP·Product code FRN·January 8, 2014
CONTAK RENEWAL
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 23, 2012
CONTINUUM, TRILOGY IT, ALLOFIT IT LINER
FDA Adverse Event
Malfunction
·ZIMMER MANUFACTURING B.V.·Product code LZO·May 26, 2015
OPTISTAR LE MULTIPAK (2-60ML SYRINGES, 90" Y TUBIN
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM·Product code DXT·May 22, 2023
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
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021