20 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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G-PGD
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Cramer Instant Cold Pack
FDA UDI
CRAMER PRODUCTS, INC.·00311960410304·Pack, Hot or Cold, Disposable
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091033101·Baltic Denture System BDLoad ↓ Mn7 PLSEum2DFm D...
Brasseler USA
FDA UDI
Provision·B504OMKM331010·
Brasseler USA
FDA UDI
Provision·00810041064813·
SMALL BONE BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919094135·KM33-101
NA
FDA UDI
STERILMED, INC.·10888551016988·SAW BLADE MICRO OSCILLATING 12 TEETH/CM STRYKER...
Phonak
FDA UDI
Phonak AG·07613275359334·Phonak Sky V50-P (beige)
NA
FDA UDI
STRYKER CORPORATION·04546540046888·Precision w/10.0mm Stop (9.2 x 0.51 x 18.4mm)
WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AMEDICA DRUG SCREEN METHAPHETAMINE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PRECISION SPECTRA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 11, 2024
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Injury
·KYPHON, INC.·Product code NDN·June 23, 2006
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Injury
·KYPHON, INC.·Product code NDN·June 20, 2006
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 1, 2013
LIFEPAK CR PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·February 28, 2011
ACCU-CHEK COMPACT PLUS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code NBW·April 23, 2008
ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·July 19, 2017
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024