18 results · 20ms · Sources: EU EUDAMED, US FDA

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BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG

FDA 510(k)
FDA Class 2 ·Orthopedic

ArgenPMMA Multi 98x16-B4

FDA UDI
ARGEN CORPORATION, THE·D818120924·Crown And Bridge, Temporary, Resin

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587P1209240·12mm PLIF Implant 9mm Wide 24mm Length

TETRIS 0°

FDA UDI
SIGNUS Medizintechnik GmbH·04047844001431·The basic shape of the KIMBA®, KIMBA® mini, MOB...

Navigator 3 Wireless Probe Battery Pack

FDA UDI
crystal-photonics GmbH·04260152884514·gamma probe system, battery pack for wireless p...

WeightRight®

FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734020753·Tungsten-Filled Hurst Esophageal Dilator, 24 Fr...

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587P12092470·12mm PLIF Implant 9mm Wide 24mm Length 7 Degrees

Scorpio

FDA UDI
Howmedica Osteonics Corp.·07613327044539·Cruciate Retaining Tibial Insert

AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

CUSTODIOL HTK SOLUTION

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

AMISTEM H HA COATED STD STEM SIZE6

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 1, 2018

SYNCHROMED II

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 20, 2013

CORE IMPACTION DRILL

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·September 26, 2014

COULTER® AC T 5DIFF CP HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code GKZ·June 13, 2011

I-STAT 6+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JGS·June 20, 2019

VENTED AUTOFEED CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 4, 2013

BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Part Number U80296-1R01, revision S

FDA Enforcement
Class II ·Ongoing·GE Healthcare Finland Oy·November 19, 2025

Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only, Quantity 1, UDI: 07613327376067

FDA Enforcement
Class II ·Terminated·Stryker Sustainability Solutions·February 3, 2021