14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D
FDA 510(k)
FDA Class 2
·Cardiovascular
SURGISTAR
FDA UDI
SURGISTAR, INC.·00878799007360·
HHM
FDA UDI
Oticon A/S·05707131288288·H160V2, DESIGNRITE 10 WL MIBU HHM
Crosslink Bonding Adhesives
FDA UDI
TP ORTHODONTICS INC·00192029000175·Crosslink Single Patient Caplets
HNM SPORTS MEDICINE
FDA UDI
HNM STAINLESS, LLC.·00812171029977·ETHOS PRO SMALL JOINT ANCHOR XL, PEEK, 2.9mm x ...
TEPHAFLEX COMPOSITE MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HNM SPORTS MEDICINE
FDA UDI
HNM STAINLESS, LLC.·00842962103852·ETHOS PRO SMALL JOINT ANCHOR XL, PEEK, 2.9mm x ...
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·January 13, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 7, 2013
PFC SIGMA/OV DOME PAT 3 PEG,32
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 30, 2011
GMK HINGE FEMORAL COMPONENT SIZE 2 LEFT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·January 29, 2016
Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-00-690. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 10, 2014
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016