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