23 results · 24ms · Sources: EU EUDAMED, US FDA

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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