20 results · 21ms · Sources: EU EUDAMED, US FDA

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MYRIAN 1.4

FDA 510(k)
FDA Class 2 ·Radiology

NuOss

FDA UDI
COLLAGEN MATRIX, INC.·00813954027791·Anorganic Bovine Bone Cortical

NuOss

FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950026784·NUOSS CORTICAL .25GRAM/.4CC PARTICLE SIZE .5-1.0MM

LEONE SPA

FDA UDI
LEONE SPA·08033707065722·INTRAORAL ELASTICS 4,5 oz 3/8" orange

NA

FDA UDI
Stryker GmbH·00886385024493·Depth Gauge

Orthopedic Instruments

FDA UDI
GM DOS REIS INDUSTRIA E COMERCIO LTDA·07901125601000·

TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM

FDA 510(k)
FDA Unclassified ·Unknown

SHANGHAI GLOVMAX ENTERPRISE POWDERFREE BLUE NITRILE EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

100" 20 DROP Y-TYPE BLOOD SET

FDA Adverse Event
Malfunction ·ICU MEDICAL, INC.·Product code FPA·November 8, 2016

WAVEWRITER ALPHA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 2, 2024

BIPOLAR INSERT CEV634-1A 350MM MOUIEL [MXI/XOM]

FDA Adverse Event
Malfunction ·XOMED MICROFRANCE MFG·Product code GEI·March 14, 2014

NEEDLE HOLDER CEV700T5 DIA 5MM TUNGSTEN

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INSTRUMENTATION S.A.S.·Product code GCJ·August 29, 2013

OT VERIO PRO METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 2, 2013

ASR ACETABULAR CUPS 50

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD.-8010379·Product code KWA·September 16, 2014

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code MDS·May 3, 2011

ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.

FDA Enforcement
Class II ·Ongoing·Brainlab AG·March 16, 2022

100" (254 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

FDA Enforcement
Class II ·Terminated·ICU Medical, Inc.·August 15, 2018

10" (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri- Connector, NanoClave" T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer, Part No. A1000, Item No. K7091-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

FDA Enforcement
Class II ·Terminated·ICU Medical, Inc.·January 15, 2014

ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.

FDA Recall
Open, Classified ·Brainlab AG Olof-palme-str. 9 Munich Germany·Product code IYE·February 25, 2022

10" (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave Clear, Tri- Connector, NanoClave" T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer, Part No. A1000, Item No. K7091-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

FDA Recall
Terminated ·ICU Medical, Inc.·Product code FPA·December 24, 2013