23 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SpeediCath Soft
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777594·LUMBAMED BASIC DORSAL STAY WM SILVER II
GERALD TISSUE FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896060197·GERALD TISSUE FORCEPS TUNGSTEN CARBIDE PLATFORM...
Cut Guide
FDA UDI
Treace Medical Concepts, Inc.·00810111222808·STEPPED INLINE CUT GUIDE, MEDIUM
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113943·B-H IRRIGATING CAN 19GA FLAT ANGLED 8MM
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780182146·Integra® Jarit® Sauerbruch Retractor, 9", 7/8" ...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306805011·Cerkes Medial Oblique Osteotome, 4mm
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319705926·Noyes Alligator Forceps 6-1/2" (16.5cm) shaft, ...
Initia Total Hip System
FDA UDI
KYOCERA CORPORATION·04547898306761·MX LINER 32-48
MICROSCAN SYNERGIES PLUS
FDA 510(k)
FDA Class 2
·Microbiology
MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDER FREE
FDA 510(k)
FDA Class 1
·General Hospital
SMR SYSTEM
FDA Adverse Event
Malfunction
·LIMACORPORATE S.P.A.·Product code KWT·February 13, 2025
EQUINOXE REVERSE 42MM HUMERAL LINER +2.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·August 7, 2023
TRUERESULT
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·October 21, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 10, 2011
ENDURANT II
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·July 1, 2013
SMR REVER. LINER RETENTIVE STD
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code PHX·September 10, 2024
H-MAX S STANDARD FEM. STEM #13
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code MEH·December 18, 2018
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
Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.
FDA Enforcement
Class II
·Terminated·SynCardia Systems Inc.·January 9, 2013