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

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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