22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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iLab Polaris Multi-Modality Guidance System
FDA 510(k)
FDA Class 2
·Cardiovascular
ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025
ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026
CETRA
FDA UDI
Orthofix US LLC·18257200122455·CETRA - RESCUE SCREWS & TACK CADDY
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668101070·WALTON CONJUNCTIVA RETRACTOR
ARSENAL PETITE LAPIDUS PLATE, R
FDA Adverse Event
Injury
·TRILLIANT SURGICAL·Product code HRS·April 3, 2020
Life Instruments
FDA UDI
Life Instrument Corporation·M930719100800·Custom O'Brien 8mm str.
Life Instruments
FDA UDI
Life Instrument Corporation·M930719100810·Custom O'Brien 8mm curved right
Life Instruments
FDA UDI
Life Instrument Corporation·M93071910081C0·8mm Teardrop Curette 10" slight curve
Cosmolock
FDA UDI
Kalitec Direct LLC·B07310K1190080·Tray Insert 1, Cosmo MIS, Arcamed
Life Instruments
FDA UDI
Life Instrument Corporation·M930719100820·Custom O'Brien 8mm curved left
DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY
FDA 510(k)
FDA Class 2
·Radiology
STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55
FDA 510(k)
FDA Class 2
·Cardiovascular
ULTRACISION HARMONIC SCALPEL HAND PIECE
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·October 9, 2008
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·June 21, 2013
REPLY
FDA Adverse Event
Injury
·SORIN CRM S.R.L.·Product code NVZ·July 29, 2011
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code LPH·October 15, 2025
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·September 21, 2022
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022
BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020