13 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MODIFICATION TO BILOK ST SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
Harvard Ionoresin Fill A2
FDA UDI
Harvard Dental International GmbH·EHAR70711151·Resin modified glass ionomer cement for restora...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197411370·Iris Scissors
115mm,...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197042000·CERA-CUT® Iris Scissors
curved...
ULTRA CATHETER SET
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010
FDA 510(k)
FDA Class 2
·Ophthalmic
JET FRESH
FDA Adverse Event
Injury
·DENTSPLY PROFESSIONAL·Product code KOJ·June 27, 2008
NAIL ADAPTER S2
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS-KIEL·Product code HSB·April 22, 2013
THINLINE II STEROX
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 27, 2011
9800MD
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·July 10, 2008
Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·December 12, 2012
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
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