24 results · 22ms · 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.

Rebar Micro Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

TiWAVE L Lumbar Cage System

FDA UDI
Kalitec Direct LLC·B07323K0101140·Distractor, Smooth Paddle, Lordotic, 14mm

InTess Lumbar Cage

FDA UDI
Kalitec Direct LLC·B07312K0101140·Distractor, Smooth Paddle, 14mm

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197116961·Trautmann Chisel, 7mm 140mm

B-P TOTAL HIP SYSTEM

FDA UDI
ENDOTEC, INC.·00814193024817·B-P HIP MODULAR FEMORAL STEM W/O HEAD, W/ BIOCO...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197116954·Trautmann Chisel, 5mm 140mm

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197116947·Trautmann Chisel, 3mm 140mm

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197116978·Trautmann Chisel, 9mm 140mm

InterPulse

FDA UDI
STRYKER CORPORATION·04546540861764·Handpiece Set with Coaxial High Flow Tip and Su...

InterPulse

FDA UDI
STRYKER CORPORATION·07613154054084·Handpiece Set with Coaxial High Flow Tip and Du...

InterPulse

FDA UDI
STRYKER CORPORATION·04546540673565·Handpiece Set with High Flow Tip and Suction Tube

ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR)

FDA 510(k)
FDA Class 2 ·Ophthalmic

Astroglide Organix Liquid

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Widex

FDA UDI
Widex A/S·05706069914535·WIDEX MOMENT MRB2D (Honey blond ) 110, Telecoil...

M SERIES

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 17, 2008

SCD EXPRESS CONTROLLER

FDA Adverse Event
Malfunction ·COVIDIEN·Product code JOW·June 27, 2013

COULTER LH 780 HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·August 5, 2011

1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip, Product Number: 0210-118-200, UDI: (01)4546540861818; 4. InterPulse Irrigation Only Handpiece with Fan Spray Tip, Product Number: 0210-218-000, UDI: (01)4546540144300 for orthopedic use.

FDA Enforcement
Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·April 4, 2018

1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip, Product Number: 0210-118-200, UDI: (01)4546540861818; 4. InterPulse Irrigation Only Handpiece with Fan Spray Tip, Product Number: 0210-218-000, UDI: (01)4546540144300 for orthopedic use.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FQH·November 9, 2017

ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015