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

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ESTECH COBRA BIPOLSR II

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

OPERATING SCISSORS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896046672·OPERATING SCISSORS CURVED BLUNT BLADES

OsteoMed

FDA UDI
OSTEOMED LLC·00845694001786·2.0mm, Rigid ZED Plate, 18mm, Right

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776186005·MAYO-NOBLE SCS - STR Bevel

LEONE SPA

FDA UDI
LEONE SPA·08033707092797·BKT 24 F1000 SELF-LIGATING 22 T-7 BH

NPAC MULTI-USE THERMOMETER, MODEL TD400

FDA 510(k)
FDA Class 2 ·General Hospital

FLUROPERM 60-OK, PARAGON HDS-OK

FDA 510(k)
FDA Class 2 ·Ophthalmic

STar™ Drive Frame Adapter

FDA UDI
FHC, INC.·00873263002247·STar(TM) Drive Offseting Frame Adapter for use ...

LOGIC TIBIA PS MOD INSRT SZ 5 9MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·August 12, 2024

PROLIFT +M PELVIC FLOOR REPAIR

FDA Adverse Event
Injury ·ETHICON, INC.·Product code OTP·May 8, 2013

FLOGARD

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 18, 2014

TI MATRIXNEURO SCREW

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code JEY·May 16, 2011

VACUETTE TUBE9NC COAGULATION SODIUM CITRATE 3.2% 13X75

FDA Adverse Event
Malfunction ·GREINER BIO-ONE GMBH·Product code GIM·April 19, 2021

BMK TIBIAL TRAY FIXED CEMENTED SIZE 4 RIGHT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL, SA·Product code JWH·April 30, 2015

Extron Electronics OEM, CAB, DVI-Male to DVI-Female Cable Assembly (14 inch.); Part #: 43-111-01 (Stryker Part #: 0100-224-131); Distributed by Stryker Communications, Flower Mound, TX 75028. (These cables are commonly used with the Switchpoint Infinity II)

FDA Recall
Terminated ·Stryker Communications·Product code GCJ·October 3, 2007

Extron Electronics OEM, CAB, DVI-I to DVI (3ft.); Part #: 43-112-01 (Stryker Part #: 0100-224-108); Distributed by Stryker Communications, Flower Mound, TX 75028. (These cables are commonly used with the Switchpoint Infinity II)

FDA Recall
Terminated ·Stryker Communications·Product code GCJ·October 3, 2007

EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

FDA Enforcement
Class II ·Terminated·Olympus Corporation of the Americas·October 7, 2015

Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

FDA Enforcement
Class I ·Terminated·Dexcom Inc·April 20, 2016

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025