MDM · Class I · 21 CFR 878.4800

FDA Product Code MDM: Instrument, Manual, Surgical, General Use

Leading manufacturers include Deroyal Industries, Inc., Surgin Surgical Instrumentation, Inc. and Ethicon, Inc..

44
Total
44
Cleared
140d
Avg days
1980
Since

FDA 510(k) Cleared Instrument, Manual, Surgical, General Use Devices (Product Code MDM)

44 devices
1–24 of 44
Cleared Aug 15, 2005
FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM
K050575
Futumeds Sdn Bhd
General & Plastic Surgery · 161d
Cleared May 18, 2005
EUTROCHAR
K050957
Special Devices, Inc.
General & Plastic Surgery · 33d
Cleared Nov 13, 2002
MICROVASIVE PULMONARY GUIDEWIRE
K022059
Boston Scientific Corp
General & Plastic Surgery · 141d
Cleared Mar 30, 1999
SAPHLIFT
K990062
Genzyme Surgical Product (Genzyme Biosurgery)
General & Plastic Surgery · 81d
Cleared Jul 09, 1998
ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG
K981579
Ethicon, Inc.
General & Plastic Surgery · 66d
Cleared Jul 19, 1994
CLAMPS AND CLIPS
K942896
Surgin Surgical Instrumentation, Inc.
General & Plastic Surgery · 29d
Cleared Feb 17, 1993
ORC ENDOSCOPIC INSTRUMENT HOLDER
K930399
O.R. Concepts, Inc.
General & Plastic Surgery · 22d
Cleared Nov 19, 1992
LACERATION REPAIR TRAY
K921988
Cypress Medical Products, Ltd.
General & Plastic Surgery · 205d
Cleared May 13, 1991
QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER
K911369
Deroyal Industries, Inc.
General & Plastic Surgery · 46d
Cleared May 08, 1991
QUALTEX SUTURE BOOTIES
K911895
Deroyal Industries, Inc.
General & Plastic Surgery · 9d
Cleared Dec 19, 1990
YANKAUER SUCTION DEVICE
K905478
Medovations, Inc.
General & Plastic Surgery · 13d
Cleared Jan 24, 1986
SHAVE PREP TRAY
K855132
Dynarex Corp.
General & Plastic Surgery · 32d
Cleared Jun 09, 1980
THE EQUALIZER
K801328
The Anspach Effort, Inc.
General & Plastic Surgery · 6d

About Product Code MDM - Regulatory Context