18 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FLEXIBLE OCCLUSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Reef TH
FDA UDI
Seaspine Orthopedics Corporation·10889981212919·Trial 9w, 15mm
Genemed®
FDA UDI
SAKURA FINETEK U.S.A., INC.·00615233010261·CISH EBER Probe, Ready-To-Use, 15 mL
GRAFT MARKER RING
FDA 510(k)
FDA Class 2
·Cardiovascular
PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 17, 2025
BD ANGIOCATH-N¿, BD AUTOGUARD¿
FDA Adverse Event
Injury
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 14, 2015
BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·August 27, 2018
VITROS CHEMISTRY PRODUCTS PHYT SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code DIP·March 13, 2013
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INT'L LTD·Product code KWA·February 16, 2011
DA VINCI SURGICAL SYSTEM
FDA Adverse Event
Other
·INTUITIVE SURGICAL, INC.·Product code NAY·February 11, 2008
BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·August 14, 2018
1) 24 G x 0.75 in. BD Angiocath" Autoguard" shielded IV catheter (0.7 mm x 19 mm) made of FEP polymer catalog number 381700 2) 24 G x 0.56 in. BD Angiocath-N" Autoguard" shielded IV catheter (0.7 mm x 14 mm) made of FEP polymer catalog number 381720
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·May 25, 2016
BASIC COSMETIC SURG. PACK CUSTOMED (USA), CODE 900-2915. CONTENTS: (2) TOWELS ABSORBENT 15" X 20" LIF (1) DRAPE BREAST/CHEST SMS L/F (1) SYRINGE 20cc W/0 NEEDLE LUER LOCK LIF (1) TUBE SUCTION CONNECT Yt" X 12' LIF (1) YANKAUER SUCTION TUBE W/0 VENT L/F (1) STERI STRIP CLOSURE%" X 4" L/F (1) BLADE SURG. #15 CARBON STEEL (1) NEEDLE HYPODERMIC 25 X 1 % LIF (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) PENCIL CAUTERY ROCKER SWITCH W/ HOLSTER LIF (1) SYRINGE 60cc THUMB CONT. RING CATH. TIP LIF (1) COVER TABLE REINFORCED 50" X 90" LIF (1) COVER MAYO STAND REINFORCED LIF (1) BAG SUTURE FLORAL (2) GOWN SOFT SMS STD. XL SET IN SLEEVE LIF (4) DRAPE UTILITY WITH TAPE L/F (4) TOWEL CLOTH HUCK LIF (1) WRAPPER 24" X 24" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·May 20, 2014
BASIC COSMETIC SURG. PACK CUSTOMED (USA), CODE 900-2915. CONTENTS: (2) TOWELS ABSORBENT 15" X 20" LIF (1) DRAPE BREAST/CHEST SMS L/F (1) SYRINGE 20cc W/0 NEEDLE LUER LOCK LIF (1) TUBE SUCTION CONNECT Yt" X 12' LIF (1) YANKAUER SUCTION TUBE W/0 VENT L/F (1) STERI STRIP CLOSURE%" X 4" L/F (1) BLADE SURG. #15 CARBON STEEL (1) NEEDLE HYPODERMIC 25 X 1 % LIF (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) PENCIL CAUTERY ROCKER SWITCH W/ HOLSTER LIF (1) SYRINGE 60cc THUMB CONT. RING CATH. TIP LIF (1) COVER TABLE REINFORCED 50" X 90" LIF (1) COVER MAYO STAND REINFORCED LIF (1) BAG SUTURE FLORAL (2) GOWN SOFT SMS STD. XL SET IN SLEEVE LIF (4) DRAPE UTILITY WITH TAPE L/F (4) TOWEL CLOTH HUCK LIF (1) WRAPPER 24" X 24" 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
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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