20 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Hailie Sensor NF0106
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772412488·PROTECT.LUMBOSTYLE BACK SUPPORT BLACK II
Consolidated Comm - Admin - 24 Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588206226·Consolidated Comm - Admin - 24 Poly White
VariAx
FDA UDI
Stryker GmbH·37613153067765·LOCKING PEGS
ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; AND WANDS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PALOMAR VECTUS LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NAIL HOLDING SCRE WGAMMA3 8X35MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·June 21, 2012
INTROCAN SAFETY®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code DYB·April 11, 2025
INTROCAN SAFETY®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·April 8, 2025
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·April 1, 2025
11.0 CM LONG ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·November 3, 2014
TRIMA ACCEL PLT, PLS, RBC SET
FDA Adverse Event
Malfunction
·CARIDIANBCT·Product code LKN·July 14, 2011
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORPORATION·Product code LLZ·July 8, 2013
CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.
FDA Enforcement
Class II
·Terminated·BD Biosciences, Systems & Reagents·January 28, 2015
INTROCAN SAFETY®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·March 20, 2025
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·April 10, 2025
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code DYB·March 18, 2026
NAVLOCK
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code OLO·November 8, 2023
BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021