31 results · 21ms · Sources: EU EUDAMED, US FDA

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OPTIS Mobile System

FDA 510(k)
FDA Class 2 ·Radiology

DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169502314·INTERBODY 2152120 SMALL - 12 DEG 20MM

Epredia

FDA UDI
RICHARD-ALLAN SCIENTIFIC COMPANY·00673693063814·The blades and knifes consumables are for use w...

Portex

FDA UDI
ICU MEDICAL, INC.·00351688011391·

Boss Instruments

FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515179622·Micro Disc Ret, self ret, 6", 120x20mm, left ho...

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690192244·Apex Revision Knee Reamer – ZIMMER SHORT FLUTES...

LUMIMED MONOCHROME LCD MONITOR, MODELS MM 20, MM 30 AND MM50

FDA 510(k)
FDA Class 2 ·Radiology

NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202

FDA 510(k)
FDA Class 2 ·Anesthesiology

CHIC

FDA UDI
Gc Orthodontics America Inc.·D78815212000201·CHIC MINI MBT 022/UR2 10T 8A

SunMed

FDA UDI
SUNMED, LLC·20889483041113·GUEDEL PVC SZ00 PINK 40mm P/50

CHIC

FDA UDI
Gc Orthodontics America Inc.·D78815212000101·CHIC MINI ROTH 022 UR2 8T 9A 0OF

INFINION CX

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 13, 2020

ONE TOUCH ULTRA

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·January 6, 2003

BINAXNOW

FDA Adverse Event
Injury ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 14, 2021

TRULIANT TIB IMP PSC INSERT SZ 6, 15MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·September 11, 2024

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

PELVICOL ACELLULAR COLLAGEN MATRIX

FDA Adverse Event
Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·May 24, 2013

ANIMAS VIBE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 15, 2015

OT ULTRAMINI METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 27, 2016

ARCHITECT C8000 SYSTEM

FDA Adverse Event
Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·October 7, 2010