20 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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