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

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DemarkQ WOW, DemarkQ POP

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814770·GENUMEDI EXTRA WIDE SILVER SIZE IV

Needle aspiration and injection

FDA UDI
KATENA PRODUCTS, INC.·00841668113608·PERIBULBAR NEEDLE 25GA 22MM

NA

FDA UDI
Stryker GmbH·07613154639939·Screw Marker 32,14

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114162·ROBINS-KRATZ POLISHING CAN, 22GA PK/10

M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130

FDA 510(k)
FDA Class 2 ·Cardiovascular

SMITH & NEPHEW PISTONS

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OZO·January 12, 2022

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 12, 2022

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 21, 2022

ILET BIONIC PANCREAS

FDA Adverse Event
Malfunction ·BETA BIONICS INC.·Product code QFG·January 2, 2026

IPUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

BRAVO

FDA Adverse Event
Malfunction ·ARIZONA DEVICE MANUFACTURING·Product code FFT·October 17, 2008

TOTAL ASR ACET IMP SIZE 60

FDA Adverse Event
Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·July 2, 2013

UNK - SCREWS: DHS/DCS

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code KTT·September 22, 2023

UNK - CONSTRUCTS: DHS/DCS

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code KTT·September 22, 2023

UNK - SCREWS: DHS/DCS

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code KTT·September 22, 2023

UNK - BIOMATERIAL - CEMENT

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code LOD·September 22, 2023

UNK - CONSTRUCTS: DHS/DCS

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code KTT·September 22, 2023

ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026