26 results
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37ms
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Sources: EU EUDAMED, US FDA
VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091033108·Baltic Denture System BDLoad Lm6 PLSEbil2DFl D4...
NA
FDA UDI
STERILMED, INC.·10888551017046·SAW BLADE MICRO OSCILLATING 12 TEETH/CM STRYKER...
Verifine
FDA UDI
Promisemed Medical Devices Inc.·00850011833759·The proposed device Insulin Syringe, a sterile ...
Verifine
FDA UDI
Promisemed Medical Devices Inc.·00850011833551·The proposed device Insulin Syringe, a sterile ...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330080·Rocker, Hinged, Locking
NA
FDA UDI
STRYKER CORPORATION·04546540046949·Precision (13.0 x 0.51 x 39.0mm)
BIOSUC
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STERIPACK STERILE DISPOSABLE SYRINGE & STERILE DISPOSABLE INSULIN SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 1, 2013
CARDIOVASCULAR PROCEDURE KIT
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code OEZ·February 28, 2011
GE OEC 9800
FDA Adverse Event
Injury
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·April 23, 2008
LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
BELIFU
FDA Adverse Event
Injury
·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020
LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·February 13, 2018
LARGE EX-FIX 11MM CRBN FBR ROD 250MM / MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
LARGE EX-FIX 11MM CRBN FBR ROD 300MM / MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012