23 results · 31ms · Sources: EU EUDAMED, US FDA

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Route 92 Medical 070 Access System

FDA 510(k)
FDA Class 2 ·Cardiovascular

Needle aspiration and injection

FDA UDI
KATENA PRODUCTS, INC.·00841668113646·RETROBULBAR NEEDLE 23GA 38MM

10M - Southwest Gas Corp

FDA UDI
Certified Safety Manufacturing, Inc.·00766588010434·10M - Southwest Gas Corp

Needle aspiration and injection

FDA UDI
KATENA PRODUCTS, INC.·00841668113622·PERIBULBAR NEEDLE 25GA 32MM

SURGICAL TITANIUM MESH SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SMS STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 4, 2025

SMS STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·January 8, 2026

SMS STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·January 29, 2026

8800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 18, 2014

ATTAIN OTW

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

GYNECARE TVT RETROPUBIC SYSTEM

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTN·July 2, 2013

BALL HEADS: MECTACER 01.29.211 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE XL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 26, 2023

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

SMS STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025

2.8MM CALIBRATED DRILL BIT QC 250MM/95MM

FDA Adverse Event
Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HTW·March 31, 2020

CUP: MPACT 01.32.148DH ACETABULAR SHELL Ø48 TWO-HOLES

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·October 28, 2022

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 12, 2025

CUP: MPACT ACETABULAR SHELL Ø60 TWO-HOLES

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·September 7, 2022