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

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IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01

FDA 510(k)
FDA Class 2 ·Immunology

DELTA

FDA UDI
Stryker Leibinger GmbH & Co. KG·07613252727842·DELTA 1.7MM STGRD-HOLE STRUT 116X14X0.5MM

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B16740920500·

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K0120500·Screwdriver, Assembled Screws SNI1

InSePtion MIS Fixation System

FDA UDI
Kalitec Direct LLC·B07314K0120500·Inserter, All-In-One

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B1674092050060·

Prime

FDA UDI
C A I INDUSTRIES CORP·00807689000204·0.20x50mm acupuncture needles (10 needles with ...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197542029·Cleaning brush 330x130, D: 50mm Packag...

VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

CGS-31A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER. TSX-101A (AQUILION ADVANCE MULTI)

FDA 510(k)
FDA Class 2 ·Radiology

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 18, 2024

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·May 18, 2011

TPRLC 133 TYPE1 PPS SO 11.0

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code KWA·May 3, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE REHABILITATION EQUIP·Product code CAW·September 16, 2014

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019