26 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING
FDA 510(k)
FDA Class 2
·General Hospital
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814770·GENUMEDI EXTRA WIDE SILVER SIZE IV
Galaxy
FDA UDI
DIOMEDICAL CO.,LTD.·08809263396682·Galaxy ACIF cage H10 x W32 x L24
PMT CORPORATION
FDA UDI
PMT CORPORATION·00650551002734·CRW 2.4mm ID - 135mm Long Bushing
BONE RASPATORY
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896052338·BONE RASPATORY DOUBLE ENDED TIPS
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A103224150·10mm H x 32mm W x 24mm L x 15 degrees ALIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A103224120·10mm H x 32mm W x 24mm L x 12 degrees ALIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A10322480·10mm H x 32mm W x 24mm L x 8 degrees ALIF
SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS
FDA 510(k)
FDA Class 2
·General Hospital
ESTECH COBRA BIPOLSR II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AMISTEM H, HA COATED STEM SIZE 1 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 19, 2016
AMISTEM H FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 26, 2025
TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCULAR, INC.·Product code HCG·May 25, 2011
SYNCHROMED
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·May 9, 2013
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDI·September 19, 2014
ENDOSCOPE 5.5MM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code GCJ·June 30, 2023
4.5 BROAD SCP PLT 26-H STER
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·November 6, 2024
The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·March 10, 2021
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