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

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DERMATOLOGICAL TREATMENT DEVICE FAMILY

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

Sonopal® hard Lacquer Al

FDA UDI
Innovation MediTech GmbH·E239M1113031·No.

SOLENT DISTA

FDA UDI
Bayer Healthcare LLC·00616258005089·SOLENT DISTA, FG PKG

LOCATOR R-Tx

FDA UDI
Zest Anchors, LLC·00840481118357·LOCATOR R-Tx Abutment For 5.0mm Premium Implant...

Life Instruments

FDA UDI
Life Instrument Corporation·M930711130310·Ring Curette #3 angled

Life Instruments

FDA UDI
Life Instrument Corporation·M930711130300·Ring Curette 13" #3 str.

K2M General Instruments

FDA UDI
VB Spine LLC·10888857530980·Trial Size 12x14x7 mm, 6°

STRATUS CS ACUTE CARE D-DIMER

FDA 510(k)
FDA Class 2 ·Hematology

RANDOX PHENOBARBITAL

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits.

FDA Recall
Terminated ·Boston Scientific Corporation·Product code DXE·July 31, 2015

UNKNOWN PATHINDER NXT OR INSTINCT JAVA IMPLANT

FDA Adverse Event
Malfunction ·ZIMMER BIOMET SPINE INC.·Product code NKB·September 24, 2022

STRATUS CS

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 11, 2015

SYMBIOS GOPUMP

FDA Adverse Event
Injury ·SYMBIOS MEDICAL PRODUCTS·Product code MEB·May 9, 2013

LD304 MATERNITY BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·May 18, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

STRATUS CS

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 9, 2015

AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits.

FDA Enforcement
Class II ·Terminated·Boston Scientific Corporation·August 19, 2015

PRONTO SPOT CHECK PULSE CO-OXIMETER

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 9, 2018

TL PEDICLE SCREW DIA. 6,5 LG 50

FDA Adverse Event
Malfunction ·ZIMMER SPINE·Product code NKB·July 9, 2019

TL PEDICLE SCREW DIA. 6,5 LG 50

FDA Adverse Event
Malfunction ·ZIMMER SPINE·Product code NKB·July 9, 2019