23 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Oxi-W System
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777587·LUMBAMED BASIC DORSAL STAY WM SILVER I
Cut Guide
FDA UDI
Treace Medical Concepts, Inc.·00810111222792·STEPPED INLINE CUT GUIDE, SMALL
GERALD FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896097520·GERALD FORCEPS TUNGSTEN CARBIDE DUST TIP
Initia Total Hip System
FDA UDI
KYOCERA CORPORATION·04547898306754·MX LINER 32-46
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306805004·Cerkes Medial Oblique Osteotome, 3mm
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDERED
FDA 510(k)
FDA Class 1
·General Hospital
EZout
FDA UDI
STRYKER CORPORATION·07613327176117·Riser Ring, 41-43mm
FEM. MODULAR HEAD - M Ø28MM 2
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code LPH·October 21, 2022
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·November 26, 2019
MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAN·November 26, 2019
PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·November 26, 2019
Acra-Cut Reusable Cranial Perforator
FDA UDI
ACRA-CUT INC·00810607000460·Acra-Cut Reusable Cranial Perforator
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·October 15, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 10, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 1, 2013
PHYSICA TT
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code MBH·December 21, 2023
HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GEI·June 30, 2025
ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only*** This device is intended to be used with Anspach Systems
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·July 2, 2014