35 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDIWORKS SLIT LAMP
FDA 510(k)
FDA Class 2
·Ophthalmic
Bur PM2-70 50K Carb Xcut Ø2.3
FDA UDI
Bien-Air Surgery SA·07630055503947·
Digital Analogue NP 3.5
FDA UDI
RP - CONEXOES RESTAURADORAS LTDA·07901059074680·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450176658·
Indus®
FDA UDI
SPINEFRONTIER, INC.·00190361001126·Invue Max, Two Level ACP, 39mm
Tibial Trial PS Insert
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215041960·
MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 2 (PHEMFILCON A) SHERICAL ( HYDROPHILIC)C
FDA 510(k)
FDA Class 2
·Ophthalmic
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·May 8, 2013
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·September 18, 2014
8800
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD.·Product code JAA·May 13, 2011
GALAXY G3 MINI 2MM X 4CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021
GALAXY G3 5MM X 15CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021
GALAXY G3 MINI 3MM X 8CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021
Open Procedure Pack, part number AMS4596 Open Procedure Pack, part number AMS4596(A Open Procedure Pack, part number AMS4596(B
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·August 29, 2012
Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
IVEA Product Part Number 16100 Model 500A
FDA Enforcement
Class II
·Terminated·Firefly Medical, Inc.·October 11, 2017
CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
FDA Enforcement
Class II
·Terminated·CME America, LLC·December 9, 2020
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014