20 results · 23ms · Sources: EU EUDAMED, US FDA

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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