12 results
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19ms
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Sources: EU EUDAMED, US FDA
FETAL BOVINE SERUM
FDA 510(k)
FDA Class 1
·Hematology
Bardia® Urethral Catheter
FDA UDI
C. R. Bard, Inc.·00801741018374·Bardia® Urethral Catheter - Red Rubber
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515209848·Tebbetts Precision Caliper, 5"
REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D
FDA 510(k)
FDA Class 2
·Clinical Toxicology
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 21, 2014
MOBICATH STEERABLE SHEATH
FDA Adverse Event
Injury
·GREATBATCH MEDICAL·Product code DYB·October 19, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·May 26, 2015
PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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