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FDA Device Enforcement Reports
View 10000 FDA Device Enforcement Reports on BEUDAMED, the Better Database on Medical Devices. These records compile FDA actions such as recalls, safety alerts, market withdrawals, and warning letters related to medical devices regulated in the United States. Each entry lists device identifiers, manufacturer information, enforcement dates, and the reason for the action to support quick assessment.
FDA Device Enforcement Reports help clinicians, manufacturers, and health-system buyers assess device safety and regulatory status. Use BEUDAMED to monitor trends, compare enforcement activity across device types, and export data for quality and compliance reviews. Regular review of enforcement reports supports post-market surveillance and informed procurement decisions.
CESAREAN PACK- - (3) ABSORBENT TOWELS 15" x 20" LIF (1) PLASTIC BOWL WITH LID 80oz. (1 0) LAP SPONGES PRE-WASH 18" x 18" XRD (2) PAD OBSTETRICAL X-LARGE ST. (1) MAYO STAND COVER REINFORCED LIF (1) DRAPE SHEET 41" x 58" SMS LIF (2) TUBE SUCTION CONNECT. Y.." X 12' LIF (1) EAR ULCER SYRINGE 2oz. LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F (1) UMBILICAL CORD CLAMP (1) SURGICAL BLADE #20 CARBON STEEL (1) TABLE COVER REINFORCED 50" X 90" LIF (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF (1) DRESSING ISLAND 4" X 1 0" (1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78" (1) BABY BLANKET PRINTED (1) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) BAG SUTURE FLORAL 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
MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.
FDA Enforcement
Class II
·Terminated·Mevion Medical Systems, Inc.·August 22, 2018
FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of contrast media into the uterine cavity for radiographic evaluation of the uterine cavity and for injection of appropriate contrast media into the fallopian tubes for evaluation of tubal patency.
FDA Enforcement
Class II
·Terminated·Cook Inc.·August 31, 2016
GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,3; GP164R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2,3; GP165R; ELAN 4 1-RING DIAMOND BURR COARSE D3,0; GP166R; ELAN 4 1-RING DIAMOND BURR+ COARSE D3,0; GP167R; ELAN 4 1-RING DIAMOND BURR++ COARSE D3,0; GP168R; ELAN 4 1-RING DIAMOND BURR COARSE D4,0; GP169R; ELAN 4 1-RING DIAMOND BURR COARSE D5,0; GP170R; ELAN 4 1-RING DIAMOND BURR COARSE D6,0; GP173R; ELAN 4 1-RING DIAMOND BURR X-COARSE D3,0; GP174R; ELAN 4 1-RING DIAMOND BURR X-COARSE D4,0; GP175R; ELAN 4 1-RING DIAMOND BURR X-COARSE D5,0; GP176R; ELAN 4 1-RING DIAMOND BURR X-COARSE D6,0; GP177R; ELAN 4 1-RING DIAMOND BURR X-COARSE D7,0; GP328R; ELAN 4 2-RING DIAMOND BURR X-COARSE D4.0; GP329R; ELAN 4 2-RING DIAMOND BURR X-COARSE D5.0; GP330R; ELAN 4 2-RING DIAMOND BURR X-COARSE D6.0; Product Usage: The ELAN 4 motor system and the Hi-Line XS handpiece are intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
FDA Enforcement
Class II
·Terminated·Aesculap Implant Systems LLC·May 24, 2017
LABOR & DELIVERY PAC - 1) NEEDLE HYPODERMIC 18G X 1% ST. (2) DRAPE UNDERBUTTOCK WITH POUCH (4) TOWELS ABSORBENT 15" X 20" ( 1) FEEDING TUBE 8FR, 15" LONG ( 1) BEANNIES BABY ( 1) SYRINGE 20cc WITHOUT NEEDLE LILOCK ( 1) UMBILICAL CORD CLAMP ST. ( 1) RECEIVING BLANKET 100% COTTON ( 1) TOWELS CLOTH HUCK (BLUE) (2) LEGGINGS W/7" CUFF 30" X 42" ( 1) BABY BLANKET 30 X 30 POLY ABS IMPERV. ( 1) BOWL PLASTIC 80oz ( 1) LID FOR BOWL 80oz CLEAR (20) GAUZE SPONGE 4" X 4" 16PLY (2) PAD OBSTETRICAL X-LARGE ST. ( 1) PACKING VAGINAL XRD 4 X 36 8PLY ( 1) TABLE COVER REINFORCED 50" X 90" ( 1) DRAPE ABDOMINAL WITH TAPE 40" X 54" (1 ) NEEDLE HYPODERMIC 21G X 1% ST. (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK (2) PVP SCRUB 8" STICK SPONGES ST. ( 1) EAR ULCER SYRINGE 2oz. ( 1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED (2) WRAPPER 30" X 30" ( 1) PVP PAINT 8" STICK SPONGE ST. (2) GLOVE SURG DERMA PRENE #7 % PF (1) TIME OUT BEACON NON WOVEN ST. (1) VACUTAINER GREEN NAHEP 10ML 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
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H7877001060010; (2)Solero Applicator 14cm PG US Catalog Number:700106001US UPN: H787700106001US0 Product Usage: The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 12, 2019
SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics
FDA Enforcement
Class II
·Terminated·Tecan US, Inc.·August 31, 2016
6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·August 27, 2014
CESAREAN PACK - (1) BABY BLANKET IMP. POLY ABS. (4) ABSORBENT TOWELS 15" x 20" LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (2) LITE GLOVES LIF (1) BOWL PLASTIC WITH LID 80 oz. (1) C-SECTION DRAPE W/ POUCH 102" X 121 " X 78" (1) UTILITY BOWL 32 oz. (10) LAP SPONGES PRE-WASHED XRD LIF (2) PAD OBSTETRICAL XLGE (1) BABY BEANNIES (1) MAYO STAND COVER REINFORCED L/F (1) DRAPE SHEET 41" X 58" SMS LIF (1) TUBE SUCTION CONNECT. X" X 12' L/F (1) EAR ULCER SYRINGE 2oz. LIF (1) RECEIVING BLANKET 100% COTION (1) YANKAUER SUCT TUBE WITHOUT VENT L/F (1) UMBILICAL CORD CLAMP (2) WRAPPER 20"X 20" (1) DRESSING ISLAND 4" X 10" (1) SCALPEL# 10 WITH HANDLE S/S (1) SCALPEL# 20 WITH HANDLE (1) TABLE COVER REINFORCED 50" X 90" L/F (1) MAYO TRAY SMALL (1) MUCUSTRAP 20cc 1 OFr. (2) GOWN LGE SMS IMPERVIOUS REINFORCED (1) SURGICAL DURAPREP SOLUTION 26mL L/F 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
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F
FDA Enforcement
Class I
·Terminated·OriGen Biomedical, Inc.·June 12, 2019