23 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Yushan X-Ray Flat Panel Detector
FDA 510(k)
FDA Class 2
·Radiology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776298258·Smith-Petersen Osteotome, 8", curved, 3/8"
Bradshaw Medical Inc.
FDA UDI
Bradshaw Medical, Inc.·00810019931055·BIT, HEX FEMALE 1/4 1/4 SQ
COE®
FDA UDI
Gc America Inc.·10386040012027·COE® SPACER TRAYS #21D Medium Lower Perforated
COE®
FDA UDI
Gc America Inc.·D6582502111·COE® SPACER TRAYS #21D Medium Lower Perforated
Kleiner KG2 system
FDA UDI
Baat Medical Products B.V.·08720246782882·Trial
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780455752·Integra® Jarit® Smith-Petersen Osteotome, Curved
Embozene®
FDA UDI
BOSTON SCIENTIFIC CORPORATION·08714729942801·Microspheres for Embolization
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·March 13, 2002
EzFuze Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
PERSONAL WARMING GEL
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197179775·Resectoscope Sheath 11 Charr.,
with 1...
Healing Abutment
FDA UDI
BICON, LLC·00813110021687·5.0 x 3.0mm Transitional Healing Abutment - 2.5...
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·June 1, 2018
RESERVOIR 3ML
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code FRN·June 11, 2018
STERLING BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·September 15, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·November 14, 2014
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 23, 2013
BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw AI-0020 20mm AcuTwist¿ Acutrak Compression Screw AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw AI-0026 26mm AcuTwist¿ Acutrak Compression Screw AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw AI-0030 30mm AcuTwist¿ Acutrak Compression Screw AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw
FDA Enforcement
Class II
·Ongoing·Acumed LLC·January 4, 2023