34 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
DOUBLE BALLOON PULL THRU W/ STUBBY COMBO
FDA UDI
MEDIVATORS INC.·40677964021822·
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00126091·
XIPHOS ZFUZE
FDA UDI
Difusion Technologies, Inc.·00853896008083·PLIF Spacer 26mm Long x 9mm Height
Medical Facets NC
FDA UDI
MEDICAL FACETS NC LLC·M933MDF20026090·3.0mm Cannulated Screw, Self-Drilling, Short Th...
Battalion
FDA UDI
ALPHATEC SPINE, INC.·00840967189024·Battalion, LLIF Trial, 0°, 26 mm Wide, 09 mm X ...
MALLARD AIR OXYGEN ACCUBLENDER
FDA 510(k)
FDA Class 2
·Anesthesiology
CARDTEL, MODEL NT-100
FDA 510(k)
FDA Class 2
·Cardiovascular
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·May 1, 2018
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 28, 2025
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
FDA Adverse Event
Death
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code NHL·May 1, 2025
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code MAX·April 19, 2018
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·March 13, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 4, 2011
CLEARSTAR PUMP
FDA Adverse Event
Malfunction
·ROSS PRODUCTS DIVISION·Product code LZH·February 8, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code NQP·September 7, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NQP·July 6, 2012
Arthroscopy Pack,900-2609, contains: (5) LAP SPONGE PREWASH 18" X 18" XRD (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH (3) STRIPS TAPE 24" X 4" (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (4) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) TUBE SUCTION CONNECT Y4" X 12' (2) ELASTIC BANDAGE WITH VELCRO 6" X 5yds (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) MERLING SKIN PREP. APPLIC 39ML (1) CAST PADDING COTTON ROLL 2" X 4yds (1) SKIN MARKER WITH RULER (1) BLADE SURGICAL# 11 CARBON STEEL (1) GOWN SURG REINFORCED LGE TOWEL WRAP (2) GOWN XL SMS IMPERVIOUS REINFORCED (2) LITE GLOVE (1) STOCKINETTE IMPERVIOUS 12" X 48" (1) TABLE COVER REINFORCED 50" X 90" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code NQP·July 6, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NQP·July 6, 2012