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

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KESTREL POSTERIOR CERVICAL SPINE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613115210·WIRE TWISTER JAWS HAVE TC (USE WITH STERNAL NEE...

NexxZr™ T / D-100-10-NT-C300-SD

FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271113320·

Reef TH

FDA UDI
Seaspine Orthopedics Corporation·10889981200800·Interbody, 11mm x 32mm x 12mm, 20 deg

Reef TA

FDA UDI
Seaspine Orthopedics Corporation·10889981192815·Interbody, 11mm x 32mm x 12mm, 20 deg

Reef TA

FDA UDI
Seaspine Orthopedics Corporation·10889981207922·Trial, 11mm x 32mm x 12mm, 20 deg

MAYO-HEGAR NEEDLE HOLDER

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896021877·MAYO-HEGAR NEEDLE HOLDER TUNGSTEN CARBIDE SERRA...

AUDIT MICROCONTROLS MICROFD BNP CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428

FDA 510(k)
FDA Class 2 ·General Hospital

INFINION 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 4, 2019

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 29, 2013

UNICEL® DXC 660I SYNCHRON® ACCESS® CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·June 17, 2011

640G INSULIN PUMP MMT-1712K

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 13, 2022

TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021