612 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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