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

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SET 3 BROCHES OUT IN

Device
EU MDR · Eu Md Class 2a ·groupe lépine·On the market·2 countries

SET 3 BROCHES IN OUT

Device
EU MDR · Eu Md Class 2a ·groupe lépine·On the market·2 countries

OT-6400 4 Pull-out Flaps without Case

Device
EU MDR · Eu Md Class 1 ·NIDEK SA·On the market·2 countries

OT-6400 4 Pull-out Flaps with Case

Device
EU MDR · Eu Md Class 1 ·NIDEK SA·On the market·2 countries

OT-6400 3 Pull-out Flaps without Case

Device
EU MDR · Eu Md Class 1 ·NIDEK SA·On the market·2 countries

OT-6400 3 Pull-out Flaps with Case

Device
EU MDR · Eu Md Class 1 ·NIDEK SA·On the market·2 countries

Burn-out

Basic UDI-DI
EU MDR · Eu Md Class 1 ·EUROTEKNIKA·1 device

MANC-OUT-NI

Basic UDI-DI
EU MDR · Eu Md Class 1 ·ACIME FRAME·1 device

Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous three-dimensional monofilament polyester textile. Its intended use is for the repair of abdominal wall hernias or other fascial deficiencies that require the addition of a reinforcing material.

FDA Enforcement
Class II ·Terminated·Sofradim Production·May 2, 2018

ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117

FDA Enforcement
Class II ·Terminated·ELITech Clinical Systems SAS·August 8, 2018

VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911 VLT600SF AIM STP; ARD568821911 VLT600SF AIM STP QL; ARD568821910 VLT600SF STP QL; ARD568811901 VLT600SF AIM STP Product Usage: The Maquet VOLISTA surgical lights are designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. StandOP VOLISTA is a system of ceiling-mounted surgical lights suited for installation in surgical suites, examining rooms, doctors surgeries and out-patient consultations.

FDA Enforcement
Class II ·Terminated·Maquet SAS·July 25, 2018

Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.

FDA Enforcement
Class II ·Terminated·BioMerieux SA·July 8, 2015

ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.

FDA Enforcement
Class II ·Terminated·BioMerieux SA·December 27, 2017

ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.

FDA Enforcement
Class II ·Terminated·BioMerieux SA·December 27, 2017

CUTTING EDGE SAS

Manufacturer
🇫🇷 France·TÜV Rheinland LGA Products GmbH

GUIDE BOUT MOUSSE ARAMIS

Device
EU MDR · Eu Md Class 1 ·groupe lépine·On the market·1 country

BROCHE 2 BOUTS MOUSSE Ø2.0L350

Device
EU MDR · Eu Md Class 2a ·groupe lépine·On the market·4 countries

CUTTING EDGE SAS

Importer
🇫🇷 France·2 Manufacturers

HZ 1457263-1

Certificate
MDR QMS·CUTTING EDGE SAS·TÜV Rheinland LGA Products GmbH

Cutting tool for meniscus repair

Basic UDI-DI
EU MDR · Eu Md Class 1 ·S.B.M. SAS·2 devices