24 results · 24ms · Sources: EU EUDAMED, US FDA

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THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES

FDA 510(k)
FDA Class 2 ·Orthopedic

CoRoent

FDA UDI
Nuvasive, Inc.·00887517635563·CoRoent Ant TLIF PEEK, 10x12x28mm 12°

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814657·GENUMEDI SILVER SIZE II

JOBST Bella Strong

FDA UDI
BSN MEDICAL, INC.·00035664009076·BELLA STRONG 15-20 MM HG ARMSLEEVE KNIT WELT SI...

Marienfeld Superior

FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317364210·

Diagon

FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030MO1022820·Trial, Bi-Convex, 12 x 34mm, 11mm

BREAST IMPLANTS

FDA Adverse Event
Malfunction ·MCGHAN MEDICAL CORP·Product code FWM·October 12, 2005

TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER

FDA 510(k)
FDA Class 2 ·General Hospital

STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE

FDA 510(k)
FDA Class 1 ·General Hospital

MBT CEM KEEL TIB TRAY SZ2

FDA Adverse Event
Injury ·9616671 DEPUY (IRELAND)·Product code NJL·May 9, 2013

HEARTMATE II SYSTEM CONTROLLER

FDA Adverse Event
Malfunction ·THORATEC CORP.·Product code DSQ·September 17, 2014

QUANTUM TTC ESOPHAGEAL BALLOON DILATOR

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC.·Product code KNQ·April 11, 2011

SURSHIELD PUR SAFETY I.V. CATHETER

FDA Adverse Event
Injury ·TERUMO CORPORATION - KOFU·Product code FOZ·December 22, 2017

BD MICROLANCE HYPODERMIC NEEDLE 30G X 0.5" YELLOW ¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·October 23, 2017

Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector, Product Code 3224-E and Product Code 3226-E

FDA Enforcement
Class II ·Terminated·ConvaTec, Inc·June 14, 2017

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

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021