15 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pacific Plus PTA Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
DOUBLE-J
FDA UDI
Gyrus ACMI, LLC·00821925006386·6.0FR(2mm) X 24 cm SURGITEK DOUBLE-J CLOSED TIP...
Dornier MedTech
FDA UDI
Dornier MedTech GmbH·04049958002618·Medilas H30 Solvo Holmium Laser with wired foot...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694041591·Ratcheting Driver Handle
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112656·BARRON CORNEAL PUNCH 8.5MM
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702390704·ELVAREX FORTE 3/THIGH HIGH/SLANT, CLOSED TOE, E...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702499506·ELVAREX 2/THIGH HIGH/OPEN TOE-ELEPHANTIASIS-VER...
VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)
FDA 510(k)
FDA Class 2
·Dental
PERFIX PLUG
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·October 17, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
FDA Adverse Event
Death
·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 2013
Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
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