12 results · 19ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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