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

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Shoreline Cervical Interbody RT System

FDA 510(k)
FDA Class 2 ·Orthopedic

BOSS Instruments

FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515027503·Weitlaner-Beckman Ret., 3 x 4 blunt, 8" Hinged

AGILIS ES STEERABLE INTRODUCER

FDA 510(k)
FDA Class 2 ·Cardiovascular

AGILIS NXT STEERABLE INTRODUCER

FDA 510(k)
FDA Class 2 ·Cardiovascular

CORIN OPTIMIZED POSITIONING SYSTEM

FDA Adverse Event
Malfunction ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 11, 2019

CORIN OPTIMIZED POSITIONING SYSTEM

FDA Adverse Event
Injury ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 2, 2019

CORIN OPTIMIZED POSITIONING SYSTEM

FDA Adverse Event
Malfunction ·OPTIMIZED ORTHO PTY LTD·Product code LZO·February 12, 2020

CORIN OPTIMIZED POSITIONING SYSTEM

FDA Adverse Event
Malfunction ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 11, 2019

CORIN OPTIMIZED POSITIONING SYSTEM

FDA Adverse Event
Malfunction ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 10, 2019

CORIN OPTIMIZED POSITIONING SYSTEM

FDA Adverse Event
Injury ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 10, 2019

CORIN OPTIMIZED POSITIONING SYSTEM

FDA Adverse Event
Injury ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 11, 2019

FUJIFILM DOUBLE BALLOON ENDOSCOPES EN-450T5/W

FDA Adverse Event
Death ·FUJIFILM CORPORATION·Product code FDA·January 26, 2024

UNKNOWN_CMF_PRODUCT

FDA Adverse Event
Injury ·STRYKER OSTEOSYNTHESIS-FREIBURG·Product code JEY·June 21, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

CORIN OPTIMIZED POSITIONING SYSTEM

FDA Adverse Event
Injury ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 10, 2019

CORIN OPTIMIZED POSITIONING SYSTEM

FDA Adverse Event
Injury ·CORIN AUSTRALIA PTY LTD·Product code LZO·December 9, 2019

CORIN OPTIMIZED POSITIONING SYSTEM

FDA Adverse Event
Malfunction ·OPTIMIZED ORTHO PTY LTD·Product code LZO·December 2, 2019

Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

FDA Recall
Open, Classified ·Philips North America·Product code LNH·April 14, 2026

Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

FDA Recall
Open, Classified ·Philips North America·Product code LNH·April 14, 2026