612 results · 21ms · Sources: EU EUDAMED, US FDA

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Sharps Needle Destruction Device

FDA Pre-Market Approval
FDA Class 2 ·NEEDLE ZAP (R)

Sharps Needle Destruction Device

FDA Pre-Market Approval
FDA Class 2 ·NEEDLE ZAP

Santis Pre Bent Rod 5.5mmx65mm

FDA UDI
Lanterna Medical Technologies GmbH·07640159550600·Santis Pre Bent Rod 5.5mmx65mm

Atos Medical

FDA UDI
ATOS MEDICAL INC.·00817126020900·2010-065 Laryngectomy Pulmonary Kit with Standa...

10 x 65mm Anodized SI Implant

FDA UDI
Osteocentric Technologies, Inc.·00810097800113·10 x 65mm Anodized SI Implant

6.5 Cancellous Bone Shaft Screw, hex, St.Steel, L 65/16 mm

FDA UDI
mahe medical gmbh·EMAH00100100650·6.5 Cancellous Bone Shaft Screw, hex, St.Ste...

mahe medical GmbH

FDA UDI
mahe medical gmbh·04050659173347·6.5 Cancellous Bone Shaft Screw, hex, _x000D_...

Integrity-SI Fusion System

FDA UDI
Lincotek Medical LLC·B57112521010065D0·10 x 65 mm Anodized SI Implant

SANTIS™ PRE BENT ROD 5.5mm X65mm -STERILE

FDA UDI
Lanterna Medical Technologies GmbH·07640159551720·SANTIS™ PRE BENT ROD 5.5mm X65mm -STERILE

CRANIAL STEREOTACTIC EQUIPMENT

FDA 510(k)
FDA Class 2 ·Radiology

BD PLASTIPAK¿ SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·May 23, 2022

AGILTRAC .035 PERIPHERAL DILATATION CATHETER

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code LIT·November 7, 2008

STARCLOSE VASCULAR CLOSURE SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·November 7, 2008

MEDTRONIC IPG

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code NVZ·July 17, 2019

MEDTRONIC IPG

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code NVZ·July 17, 2019

AXSYM DIGOXIN III

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007

OT VERIO TEST STRIPS

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·February 11, 2011

Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk)

FDA Enforcement
Class II ·Ongoing·Galt Medical Corporation·June 21, 2023

Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk)

FDA Recall
Open, Classified ·Galt Medical Corporation·Product code DYB·May 8, 2023