17 results · 29ms · Sources: EU EUDAMED, US FDA

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Mako Total Knee Application

FDA 510(k)
FDA Class 2 ·Neurology

Micro Lamina Spreader

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896104723·Micro Lamina Spreader With Speed Lock Mini Tip

Bausch + Lomb

FDA UDI
Bausch & Lomb Incorporated·00757770436651·PICK OVAL WDW HOUS 30DEG 2/3MM

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776177256·WEISMAN-PEDS SPEC R Large . .

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197071253·Sculpo Retractor 25x300...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197071246·Deaver Retractor 25x230...

JEDMED

FDA UDI
JEDMED INSTRUMENT COMPANY·M633301705810·PICK OVAL WINDOW HOUSE 30-DEG .66MM

PROPATCH SOFT TISSUE REPAIR MATRIX

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

SILVER ALGINATE II WOUND DRESSING

FDA 510(k)
FDA Unclassified ·Unknown

BD RELION INSULIN SYRINGE 1/2 ML, 31 G X 8 MM

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·November 6, 2017

HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·January 18, 2018

RESTORE ULTRA

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·October 14, 2014

HEARTSTART MRX

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 28, 2013

ACCU-CHEK ® MULTICLIX

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·July 21, 2011

G7 ACETABULAR SYSTEM OSSEOTI 3 HOLE SHELL 52MM E

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·March 8, 2024

G7 SCREW 6.5MM X 30MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code PBI·March 8, 2024

CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024