18 results · 22ms · Sources: EU EUDAMED, US FDA

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ProCinch Adjustable Loop Device

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526768505·GENUMEDI PSS GREEN VI

AGXO

FDA UDI
Oticon A/S·05707131288592·H110V2, DESIGNRITE 10 WL SIL AGXO

OSS™ Orthopedic Salvage System

FDA UDI
Biomet Orthopedics, LLC·00880304239395·

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197541800·RZ Tebbet Breast Retractor 150x16...

HNM MEDICAL

FDA UDI
HNM STAINLESS, LLC.·00842962104767·FULL RADIUS BLADE, SMALL JOINT, 2.9MM, S

DORNIER HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·DORNIER MEDTECH AMERICA, INC.·Product code LNK·July 13, 2007

ABL835 FLEX ANALYZER WITH PLEURAL PH

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

OSSAPLAST ORTHO

FDA 510(k)
FDA Class 2 ·Orthopedic

HNM MEDICAL

FDA UDI
HNM STAINLESS, LLC.·00842962102770·DISPOSABLE ARTHROSCOPIC 2.9mm FULL RADIUS SHAVE...

PRODIGY AUTOCODE

FDA Adverse Event
Injury ·OK BIOTECH CO., LTD.·Product code NBW·March 31, 2016

BALLOON

FDA Adverse Event
BOSTON SCIENTIFIC·Product code KNQ·June 21, 2011

UNKNOWN ZIMMER HIP

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JDI·March 19, 2013

PRECISION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 5, 2008

TREVO XP PROVUE 4MM X 30MM

FDA Adverse Event
Injury ·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code NRY·July 24, 2020

KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " Product Usage: Laryngeal airway

FDA Enforcement
Class II ·Terminated·King Systems Corp.·November 28, 2012

Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

FDA Enforcement
Class I ·Terminated·Dexcom Inc·April 20, 2016

Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024