222 results · 22ms · Sources: EU EUDAMED, US FDA

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SECURELOC; ADVANCINTRODUCER

FDA 510(k)
FDA Class 2 ·Cardiovascular

EASYLIFE

FDA UDI
Respironics, Inc.·00606959001312·EasyLife Mask w/Headgear, Medium Wide, Internat...

MedGyn Pessary Ring w/o support #7

FDA UDI
MEDGYN PRODUCTS, INC.·M803050023·Pessary ring is used to treat uterine prolapse.

Ni-Ti - Archwire

FDA UDI
ORMCO CORPORATION·00889989025347·PREF.LING.ARCH NI-TI UP16 SZ2 PK/10

Kalitec Special

FDA UDI
Kalitec Direct LLC·B073DRK0100230·SNII Awl Tap, 7.50mm

Matira

FDA UDI
Kalitec Direct LLC·B07307K0100230·Assembly, Caddie, 4L Plates, Hinged

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0100230·Caddie, Lid, Rods, Adjustable Cross Links, and ...

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 3, 2025

DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING

FDA 510(k)
FDA Class 2 ·Hematology

FRIENDLY LIGHT ER:YAG PULSED LASER

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

VIASPAN

FDA Adverse Event
Other ·BARR LABS·Product code KDL·September 10, 2007

BOOT ASSEMBLY

FDA Adverse Event
Malfunction ·MAKO SURGICAL CORP.·Product code OLO·August 29, 2019

ASR ACETABULAR CUPS 60

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·April 10, 2013

SYSTEM 5 SAGITTAL SAW

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·March 14, 2011

SPRINT FIDELIS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·May 8, 2008

Disetronic H-TRONplus Insulin Pump; catalog # 8050023 [clear case], 8050064 [blue case], 8050021 [solid-color case] and 8050071 [yellow case].

FDA Recall
Terminated ·Roche Diagnostics Corp.·Product code LZG·July 21, 2003

BOOT ASSEMBLY

FDA Adverse Event
Malfunction ·MAKO SURGICAL CORP.·Product code OLO·September 5, 2019

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·BIOTRONIK ICD FAMILIES

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T DX,