ClearanceBrief
Company ยท US

Custom Medical Specialties, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 1995. Name variants (Inc, Corp, punctuation) are merged.

1510(k) clearances (0 in 12 months)
18recalls (0 in 12 months)
1recalls that name a 510(k)

Product codes

CodeDeviceRecords
LROGeneral Surgery Tray12
LRPTray, Surgical4
FCHTray, Biopsy, Without Biopsy Instruments1
JAYSupport, Breathing Tube1
KKXDrape, Surgical, Antimicrobial1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jan 27, 1995K944988CUSTOM MEDICAL SUSPENSION STRAP
Custom Medical Specialties, Inc.
JAY

Latest recalls

DateFirm and productCodeLinked 510(k)
Sep 20, 2016Custom Medical Specialties, Inc.
CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.
Open, Classified
FCHNone listed
Feb 12, 2014Custom Medical Specialties, Inc.
5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. P
Terminated
KKXK882724
Sep 20, 2012Custom Medical Specialties, Inc.
BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Terminated
LRONone listed
Sep 20, 2012Custom Medical Specialties, Inc.
CMS-5284 Custom Myelogram Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Terminated
LRONone listed
Sep 20, 2012Custom Medical Specialties, Inc.
CMS-4975 HSG Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Terminated
LRONone listed
Sep 20, 2012Custom Medical Specialties, Inc.
CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Terminated
LRONone listed
Sep 20, 2012Custom Medical Specialties, Inc.
CMS-8495-R5 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Terminated
LRONone listed
Sep 20, 2012Custom Medical Specialties, Inc.
CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiology Drainage Pack containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in s
Terminated
LRONone listed
Sep 20, 2012Custom Medical Specialties, Inc.
CMS-8162-R1 Fox Chase Specials Pack containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Terminated
LRONone listed
Sep 20, 2012Custom Medical Specialties, Inc.
CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Terminated
LRONone listed
Sep 20, 2012Custom Medical Specialties, Inc.
CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Terminated
LRONone listed
Sep 20, 2012Custom Medical Specialties, Inc.
CMS-4316 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Terminated
LRONone listed
Sep 20, 2012Custom Medical Specialties, Inc.
CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product Usage: Usage: The PVP contained in the kit is used in skin prep
Terminated
LRONone listed
Sep 20, 2012Custom Medical Specialties, Inc.
CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usage: Usage: The PVP contained in the kit is used in skin prep
Terminated
LRONone listed
Sep 7, 2012Custom Medical Specialties, Inc.
CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution
Terminated
LRPNone listed
Sep 7, 2012Custom Medical Specialties, Inc.
CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution The PV contained in the kit is used in skin prep
Terminated
LRPNone listed
Sep 7, 2012Custom Medical Specialties, Inc.
CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in skin prep
Terminated
LRPNone listed
Sep 7, 2012Custom Medical Specialties, Inc.
CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in skin prep
Terminated
LRPNone listed
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