98 results · 14ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Brow Pack, Kit part number PSS1785(A, PSS1785(B, and PSS1785(C. convenience custom kits used for general surgery in hospital operating room

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(A, convenience custom kits used for general surgery in hospital operating room

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

Minor Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(A. convenience custom kits used for general surgery in hospital operating room

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, PSS2798, PSS2798(A, PSS2798(B, PSS3054, PSS3463, TVS4011NI(J, TVS4028(A, and TVS4070. convenience custom kits used for general surgery in hospital operating room

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product Usage: The reVive Light Therapy Pain Relief Device is a device designed to deliver LED light spectrum in 880nm and 660nm directly into the body tissue to increase circulation and temporarily relieve pain associated with muscle spasms, arthritis, general aches and strains.

FDA Enforcement
Class II ·Terminated·LED Technologies, LLC·May 4, 2016

Lithotomy Pack, Kit number AMS2333 and AMS2333(A convenience custom kits used for general surgery in hospital operating room

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

Body Contour Pack, Kit part number PSS1749 convenience custom kits used for general surgery in hospital operating room

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. LGC 13G (13G x 185mm), Sterile.

FDA Recall
Terminated ·Globalmed Logistix·Product code MUU·December 15, 2015

Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS2351, and PSS3073. convenience custom kits used for general surgery in hospital operating room

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

Biograph mCT X-4R, Model Number 10248670

FDA Recall
Terminated ·Siemens Medical Solutions USA Inc.·Product code KPS·July 14, 2015

Biograph mCT S(64)-4R, Model Number 10248672

FDA Recall
Terminated ·Siemens Medical Solutions USA Inc.·Product code KPS·July 14, 2015

Biograph mCT Flow Edge-4R, Model Number 10528955

FDA Recall
Terminated ·Siemens Medical Solutions USA Inc.·Product code KPS·July 14, 2015

Biograph mCT S(40)-4R, Model Number 10248671

FDA Recall
Terminated ·Siemens Medical Solutions USA Inc.·Product code KPS·July 14, 2015

Custom Pack - with Introducer Kit, Kit number TVS4011NI(K and TVS4011NI(L convenience custom kits used for general surgery in hospital operating room

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

Biograph 6-4R TruePoint w/ TrueV, Model Number 10097290

FDA Recall
Terminated ·Siemens Medical Solutions USA Inc.·Product code KPS·July 14, 2015

Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302

FDA Recall
Terminated ·Siemens Medical Solutions USA Inc.·Product code KPS·July 14, 2015

Biograph 64-3R TruePoint w/ TrueV, Model Number 10097301

FDA Recall
Terminated ·Siemens Medical Solutions USA Inc.·Product code KPS·July 14, 2015

SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743

FDA Recall
Terminated ·Siemens Medical Solutions USA Inc.·Product code KPS·July 14, 2015

General Pack I, Kit number CMP1811(B convenience custom kits used for general surgery in hospital operating room

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

Transvaginal Pack, Kit number CMP1767 convenience custom kits used for general surgery in hospital operating room

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016