17 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE
FDA 510(k)
FDA Class 2
·Orthopedic
LuxaPost
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG1107830·Glass fiber-reinforced pre-silanized composite ...
JOBST Men's Dress
FDA UDI
BSN MEDICAL, INC.·00035664107833·MEN'S DRESS 8-15 MM HG KNEE HIGH CLOSED TOE EXT...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306818318·AXS Instrument Holder- Hex QC Holder- Stainless
IRIS SCISSORS CVD.S/S 110MM
FDA Adverse Event
Injury
·AESCULAP AG·Product code LRW·August 19, 2022
COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
2.0/2.4 CANNULATED SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RESPIRONICS
FDA Adverse Event
Malfunction
·Product code MNT·April 8, 2021
PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·August 15, 2019
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAA·April 3, 2013
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 9, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 1, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 14, 2008
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·July 17, 2013
HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024