16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Additive Orthopaedics Locking Lattice Plate
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526781719·LUMBAMED FACET 3 POINT SILVER IV
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197067324·Ollier Retractor, 225 mm
36 x 6...
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973107279·TRIAL 90-SRK-170214 POLY UCCS 2X14MM
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197067317·Ollier Retractor
22.5 c...
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
FDA Adverse Event
Malfunction
·NUVASIVE SPECIALIZED ORTHOPEDICS, INC.·Product code PGN·March 1, 2021
ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026
OT VERIO FLEX METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 1, 2015
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 20, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MPRI·Product code DTB·June 14, 2013
AUTOTOME RX SPHINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·September 11, 2008
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
FDA Enforcement
Class II
·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022