43 results · 28ms · Sources: EU EUDAMED, US FDA

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XEROS DRY MOUTH PUMP

FDA 510(k)
FDA Unclassified ·Unknown

TruTemp C&B

FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724N1101161·A3

Cook

FDA UDI
COOK INCORPORATED·00827002141100·Philips Follower Dilator

Aspida

FDA UDI
ALPHATEC SPINE, INC.·00190376115917·16mm LUMBAR PLATE,TF

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450159491·

TiWAVE L Lumbar Cage System

FDA UDI
Kalitec Direct LLC·B07323K0101160·Distractor, Smooth Paddle, Lordotic, 16mm

InTess Lumbar Cage

FDA UDI
Kalitec Direct LLC·B07312K0101160·Distractor, Smooth Paddle, 16mm

Leva® Anterior Interbody System

FDA UDI
Spine Wave, Inc.·10840642117431·Modular Spacer, 30 mm (W) x 26 mm (L) x 19 mm (...

PLANMED SOPHIE, PLANMED SOPHIE CLASSIC

FDA 510(k)
FDA Class 2 ·Radiology

LASERTOUCHONE (OTC)

FDA 510(k)
FDA Class 2 ·Neurology

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197410977·Scalpel Handle No. 3L 210mm,...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197490016·Scalpel Handle No. 3XXL 360mm,...

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 12, 2023

Widex

FDA UDI
Widex A/S·05706069971897·WIDEX MOMENT MBB2 110 (Dark cherry)

Widex

FDA UDI
Widex A/S·05706069884180·WIDEX MOMENT MRR2D (Dark cherry ) 110, RC coil,...

Widex

FDA UDI
Widex A/S·05706069852028·WIDEX MOMENT MBB3D 110 (Dark cherry)

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 12, 2023

T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OZO·January 31, 2020

Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

FDA Recall
Open, Classified ·GE Healthcare, LLC·Product code CBK·April 18, 2022

RELIANCE 4-FRONT

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code NVY·April 15, 2026