Atlas FDA

MMP

15 FDA 510(k) clearances · Product code

105 daysmedian time to decision
517 days90th percentile
15clearances measured

FDA profile

Official device name
Cover, Barrier, Protective
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4370
Medical specialty
General, Plastic Surgery
Flags
Third-party review eligible
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RecordFirmDate
MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN (K091178)Mtp Medical Technical Promotion GmbH2009-07-31
LIGHT DRAPE (K043234)Wrapped IN Comfort2005-05-25
GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS (K041501)Guangzhou Fortunique , Ltd.2004-11-30
INCUBATOR CAPE (K040794)Wrapped IN Comfort2004-06-10
MEDLINE BAND BAGS AND EQUIPMENT COVERS (K032065)Medline Industries, Inc.2003-09-22
SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09 (K023540)Valumed2003-02-04
MEDSURG EQUIPMENT COVERS (K014239)International Medsurg Connection2002-02-19
ULTRASOUND SYSTEMS DRAPE (K970885)Protek Medical Products, Inc.1997-09-22
COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER (K962288)Pinnacle Products, Inc.1997-01-30
EQUIPMENT COVERS (K961699)United States Surgical, A Division of Tyco Healthc1996-08-23
PROTOUCH OVERGLOVE (K952241)Cottrell, Ltd.1995-08-07
STERILE EQUIPMENT COVERS (K931417)Custom Medical Products, Ltd.1995-07-06
SURGICAL MICROSCOPE DRAPE (K944198)Hydro-Med Products, Inc.1994-11-27
STERILE BARRIER SLEEVE AND COVER (K930552)Patient Safety Products, Inc.1994-07-05
BANDBAG, WRAP, STERILE (K820692)Contour Fabricators, Inc.1982-05-03

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Every clearance here is in the API, with alerts when new ones post.