15 results
·
49ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
NEONATAL BIOTINIDASE KIT, MODEL 3018
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NOOSA Anterior Lumbar Plate
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215019709·
exsalt CMC Gelling Fiber Dressing
FDA UDI
Exciton Technologies Inc·07540127000222·exsalt™ CMC Gelling Fiber Dressing is a soft, s...
P-STIM SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
BIOARC SP SLING KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ROD, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019
UNKNOWN LINER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·February 10, 2015
ILIAC SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·October 16, 2019
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 2, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 15, 2014
PFC SIGMA CRVD INSERT SZ3 10MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, DEPUY CORK·Product code JWH·July 30, 2008
POLARIS SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·January 8, 2020
POLARIS TRANSLATION SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·February 26, 2014
Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML/W028 Adaptor, Intl, Product No. 404128; Aqauapak 428 SW, 440 ML W/028 Adaptor, Intl, Product No. 404428; Aquapak 728 SW, 760 ML W/028 Adaptor, Product No. 037-28; Aquapak SW/EAU Sterile, 760 ML W/Adaptor, Product No. 037-28C; Aquapak 728 SW, 760 ML W/28 Adaptor, French, Product No. 037-02F; Aquapak 733 SW, 760 ML W/033 Adaptor, Product No. 037-33; Aquapak 735 HNS, 760 ML W/028 Adaptor, Product No. 037-35; Aquapak 739 FNS, 760 ML W/028 Adaptor, Product No. 037-39; Aquapak 0.9% NACL, 760 ML W/Adaptor, Product No. 037-39C; Aquapak 770 HNS, 760 ML W/033 Adaptor, Product No. 037-70; Aquapak 1028 SW, 1070 ML W/028 Adaptor, Product No. 041-28; Aquapak SW/EAU Sterile, 1070 ML W/Adaptor, Product No. 041-28C; Aquapak 1033 SW, 1070 ML W/033 Adaptor; Product No. 041-33; Aquapak 1035 HNS, 1070 ML W/028 Adaptor, Product Code 041-35; Aquapak 428 SW, 440 ML W/028 Adaptor, Product No. 044-28; Aquapak SW/EAU Sterile, 440 MLW/Adaptor, Product No. 044-28C; Aquapak 428 SW, 440 ML W/028 Adaptor, French, Product No. 044-28F; Aquapak 433 SW, 440 ML W/033 Adaptor, Product No. 044-33; Aquapak 435 HNS, 440 ML W/028 Adaptor, Product No. 044-35; Aquapak 470 HNS, 440 ML W/033 Adaptor, Product No. 044-70. Used in anesthesiology.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·December 10, 2014