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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)

FDA 510(k)
FDA Class 2 ·General Hospital

Batrik Blue Cloud-Gel Anti-Fatigue Floor Mats

FDA UDI
Batrik Medical Manufacturing Inc·00690521011618·Blue Cloud-GelTM Anti-Fatigue Mat, 18" x 24" (4...

START VPS

FDA UDI
DANVILLE MATERIALS, LLC·00816594021297·START VPS,HEAVY,STF,BITE,KIT 2

JOBST Custom Seamless Soft

FDA UDI
BSN-Jobst GmbH·04059993125708·CUSTOM SEAMLESS SOFT 1/CHAP STYLE/OPEN TOE/CRAN...

4.0 X 24mm CANN SCREW FASTENER Ti SH THD

FDA UDI
Osteocentric Technologies, Inc.·00810074303057·4.0 X 24mm CANN SCREW FASTENER Ti SH THD

JOBST Custom Seamless Soft

FDA UDI
BSN-Jobst GmbH·04059993143252·CUSTOM SEAMLESS SOFT 2/CHAP STYLE/OPEN TOE/CRAN...

Powered Loading System (PLS) (Component)

FDA UDI
LIFEPORT, LLC·00810050861854·RAIL ASSEMBLY, GLOBAL * (PLS)

NEEDLE SFTYGLD 27X5/8 RB

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·June 29, 2020

WVSM Wireless Vital Signs Monitor

FDA UDI
ATHENA GTX, INC.·B3945700024010·Shoulder Strap-Black

Compumedics Quik-Cap

FDA UDI
COMPUMEDICS LIMITED·09342451006035·Quik-Cap Neoprene Flexnet - Grael 128 Ch Xlarge

AMT THERAPEUTIC TABLE, MODEL 748AMT

FDA 510(k)
FDA Class 2 ·Physical Medicine

VAPOTHERM, MODEL 2000I

FDA 510(k)
FDA Class 2 ·Anesthesiology

BD SAFETYGLIDE NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·July 9, 2020

SURGITEK REPLICON SILICONE BREAST IMPLANT

FDA Adverse Event
Malfunction ·MEDICAL ENGINEERING CORP.·Product code FTR·June 8, 1994

TANDEM T:SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES·Product code LZG·June 10, 2014

PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG

FDA Adverse Event
Malfunction ·MEDELA, INC.·Product code HGX·March 8, 2013

THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-L-TE4BE1EB

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, IRVINE·Product code OAD·January 28, 2011

CUP: MPACT 01.32.156MH ACETABULAR SHELL Ø56 MULTI-HOLE

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·February 21, 2022

Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·January 24, 2024

Spectral CT. Computed tomography X-ray system.

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·July 2, 2025