18 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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