21 results
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26ms
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Sources: EU EUDAMED, US FDA
YES-NO VOICE BOX 7011
FDA 510(k)
FDA Class 2
·Physical Medicine
ACUFEX
FDA UDI
Smith & Nephew, Inc.·03596010481511·SOD ACUFEX PRO 1.5MM UPBITER
Welch Allyn, Inc.
FDA UDI
WELCH ALLYN, INC.·00732094088441·Welch Allyn SureSight Vision Screener; Automati...
Welch Allyn, Inc.
FDA UDI
WELCH ALLYN, INC.·00732094088427·Welch Allyn SureSight Vision Screener; Automati...
Welch Allyn, Inc.
FDA UDI
WELCH ALLYN, INC.·00732094322385·REFURB SPOT VISION SCREENER W CASE UK
Welch Allyn, Inc.
FDA UDI
WELCH ALLYN, INC.·00732094214154·VS100 UDI BASE UNIT
Welch Allyn, Inc.
FDA UDI
WELCH ALLYN, INC.·00732094212235·Welch Allyn VS100 Spot Vision Screener with Wri...
Welch Allyn, Inc.
FDA UDI
WELCH ALLYN, INC.·00732094088281·Welch Allyn SureSight Autorefractor; Automatica...
Welch Allyn, Inc.
FDA UDI
WELCH ALLYN, INC.·00732094088267·Welch Allyn SureSight Autorefractor; Automatica...
Welch Allyn, Inc.
FDA UDI
WELCH ALLYN, INC.·00732094088250·Welch Allyn SureSight Autorefractor; Automatica...
Welch Allyn, Inc.
FDA UDI
WELCH ALLYN, INC.·00732094355970·SPOT VISION SCREENER EMR APPLICATION
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515226630·Buck Ear Curette, 3.0mm, sz 3, str, dull
GEIGER NEEDLE ADAPTER, MODEL 406
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM)
FDA 510(k)
FDA Class 2
·Cardiovascular
DIACAM (510(K) K 901019)
FDA Adverse Event
Other
·SIEMENS MEDICAL SYSTEMS·Product code KPS·March 13, 2001
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MGB·June 30, 2014
SPARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code OTN·January 3, 2013
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FPO·November 10, 2010
Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version: Software version 3.2.0.1 Product Description: Welch Allyn Spot Vision Screener VS100, FDA product code name: Refractometer, ophthalmic One unit per package
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·March 25, 2026
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025