16 results · 22ms · Sources: EU EUDAMED, US FDA

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TRU RSV

FDA 510(k)
FDA Class 1 ·Microbiology

DP-REPAIR

FDA UDI
Denplus Inc·D8451071101·DP-REPAIR-F, SPL, 454 g

NA

FDA UDI
KEY SURGICAL, INC.·10849771048845·K-Wires, Double trocar, .035-inch (0.9mm) diame...

K-Wire w. double end trocarpoint 0.90mm/102mm, 6 pcs./unit

FDA UDI
mahe medical gmbh·EMAHKM711010·K-Wire w. double end trocarpoint 0.90mm...

LOCATOR R-Tx

FDA UDI
Zest Anchors, LLC·00840481113055·LOCATOR R-Tx Abutment for 3.4mm XiVE Connection...

mahe medical GmbH

FDA UDI
mahe medical gmbh·04050659484023·K-Wire w. double end trocarpoint _x000D_...

XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4

FDA 510(k)
FDA Class 2 ·Neurology

RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

BD PLASTIPAK¿ 1ML SYRINGE WITH 27G X 1/2" NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMF·April 20, 2017

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·April 22, 2013

PRECISION®

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 27, 2011

GE OEC 9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·July 10, 2008

BABY CONTROL MOBILE INFANT WARMER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·September 2, 2013

BD TEXIUM¿ NEEDLE-FREE SYRINGE

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FMF·November 29, 2022

STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10134 Sterrad 100NX Express Cycle Kit. 10135 Sterrad 100NX Express Cycle Upgrade Kit. 10137 Sterrad 100NX Duo Cycle Upgrade kit. 14325 Cyclesure Challenge Pack Kit. 20103 Sterrad 100NX Test Pack Kit. 20228 Sterrad 100NX Intl Validation Kit. 20229 Sterrad 100NX Validation Kit, USA. 20232 Sterrad 50/100S Validation Kit. 20236 Sterrad 50/100S Validation Kit. 20248 Sterrad 100NX Express Validation Kit. 20253 Sterrad NX Validation Kit. 20254 Sterrad NX Validation Kit Domestic, US. The Sterrad Cyclesure 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilization System cycles.

FDA Enforcement
Class II ·Terminated·Advanced Sterilization Products·December 19, 2012

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