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