19 results · 27ms · Sources: EU EUDAMED, US FDA

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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