MEDITECH

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3005037781	3005037781	MEDITECH GROUP, LLC	1	Y	2026-01-01	2108 N St, Suite 8474 Sacramento CA US 95816
3010439239	3010439239	MEDITECH SYSTEMS LIMITED	1	N	2026-01-01	shrublands Estate Shearstock Shaftesbury Dorset GB SP79PT
3011346938	3011346938	MEDITECH ENDOSCOPY LTD	1	N	2026-01-01	Suite 1 Bowden Terminal Luckyn Lane Basildon Essex GB SS14 3AX
3005037781	3005037781	MEDITECH GROUP, LLC	1	N	2020-04-25	25 PIPPEN PLACE NEW CITY NY US 10956
3009405289	3009405289	Meditech Spine, LLC	1	Y	2020-04-25	1447 Peachtree St NE Ste 440 Atlanta GA US 30309

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
180532	1765096876	K192713	Altera Filter and HME/Filter	CAH	2020-03-16
184447	1614338276	K191011	Scope ProTech	OCU	2019-05-07
144066	1616610323	K181543	Cure™ OPEL-C Plate System	KWQ	2018-08-31
144066	1982889441	K180090	Cure™ Lumbar Plate System	KWQ	2018-04-23
144066	1311840214	K171538	Cure™ Lumbar Plate System	KWQ	2017-06-16
144066	1395048615	K170395	Talos® Lumbar (HA) PEEK IBF Devices	MAX	2017-06-02
144066	2008407122	K160604	Cure™ Anterior Cervical Plate (ACP) System	KWQ	2016-07-01
144066	1042648363	K150788	Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C(HA) Cervical Intervertebral Body Fusion Devices	ODP	2015-10-14
144066	1127832173	K142345	Talos-C(HA) Cervical Intervertebral Body Fusion Devices	ODP	2015-02-22
144066	1925449017	K122850	TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES	ODP	2013-03-28
144066	1525957828	K090707	TALOS INTERVERTEBRAL BODY FUSION DEVICE	MAX	2009-07-15
184447	1107209298
144066	1411320459
68262	1567883869
144066	1661354432
68262	1693713770
184447	1728448544
68262	2057144902
180532	1009878626
180532	1133948638
180532	1295149731
180532	1422076427
180532	1450487059
180532	1554747049
180532	1563061912
180532	1608242358
180532	1915636332
180532	1937235340
180532	1964504385

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
KWQ	4	2018-08-31
ODP	3	2015-10-14
OCU	2	2019-05-07
MAX	2	2017-06-02
CAH	1	2020-03-16

PMN#

BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free

2022-04-17

Meditech Gloves SDN BHD

Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)

2021-05-07

Meditech Gloves SDN BHD

Cure 2.0 Anterior Cervical Plate (ACP) System

2021-03-18

Meditech Spine, LLC

Meditech ABPM-06 (BP6)

2021-02-10

Meditech Ltd.

Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System

2020-09-11

Meditech Spine, LLC

Cure™ Lumbar Plate System

2020-05-12

Meditech Spine, LLC

Scope ProTech

2019-05-07

Meditech Endoscopy Ltd

Cure™ OPEL-C Plate System

2018-08-31

Meditech Spine, LLC

Cure™ Lumbar Plate System

2018-04-23

Meditech Spine, LLC

Cure™ Lumbar Plate System

2017-06-16

Meditech Spine, LLC

Talos® Lumbar (HA) PEEK IBF Devices

2017-06-02

Meditech Spine, LLC

Cure™ Anterior Cervical Plate (ACP) System

2016-07-01

MEDITECH SPINE, LLC

Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C(HA) Cervical Intervertebral Body Fusion Devices

2015-10-14

MEDITECH SPINE, LLC

Talos-C(HA) Cervical Intervertebral Body Fusion Devices

2015-02-22

MEDITECH SPINE, LLC

TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES

2013-03-28

MEDITECH ADVISORS, LLC

TALOS INTERVERTEBRAL BODY FUSION DEVICE

2009-07-15

MEDITECH ADVISORS, LLC

BIOFLEX LD-R100 TREATMENT HEAD

2008-12-18

MEDITECH INTERNATIONAL, INC.

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2008-10-30

MEDITECH Medical Information Technology, Inc.

LD-I 75 AND LD-I 200

2008-04-02

MEDITECH INTERNATIONAL, INC.

MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05

2007-08-03

MEDITECH KFT.

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2007-02-06

MEDITECH Medical Information Technology, Inc.

BIOFLEX PRESCRIPTION SYSTEM AND RELATED TREATMENT HEADS

2006-03-13

MEDITECH INTERNATIONAL, INC.

MEDITECH MODEL ABPM-04

2005-11-18

MEDITECH KFT.

BIOFLEX LD-175 AND LD-1200 TREATMENT HEADS

2005-02-24

MEDITECH INTERNATIONAL, INC.

BIOFLEX PROFESSIONAL THERAPY SYSTEM

2003-04-10

MEDITECH INTERNATIONAL, INC.

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

2000-02-08

MEDITECH Medical Information Technology, Inc.

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

1999-03-19

MEDITECH Medical Information Technology, Inc.

NIDA-5/RT, DRUG OF ABUSE CONTROLS

1994-09-14

MEDITECH

SPECTROLYSE FACTOR VII:C

1993-12-06

MEDITECH, INC.

GUDID#

Protech XL - ENDOSCOPIC STORAGE COVER

MEDITECH ENDOSCOPY LTD

2026-01-30

Protech S - ENDOSCOPIC STORAGE COVER

MEDITECH ENDOSCOPY LTD

2026-01-30

Protech XL - ENDOSCOPIC STORAGE COVER

MEDITECH ENDOSCOPY LTD

2026-01-30

Protech S - ENDOSCOPIC STORAGE COVER

MEDITECH ENDOSCOPY LTD

2026-01-30

Protech L - ENDOSCOPIC STORAGE COVER

MEDITECH ENDOSCOPY LTD

2026-01-28

Protech L - ENDOSCOPIC STORAGE COVER

MEDITECH ENDOSCOPY LTD

2026-01-28

CURE LP - S1-9-00051-45

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00051-44

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00051-43

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00051-42

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00051-41

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00051-40

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00051-39

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00051-38

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00051-37

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00051-36

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00051-35

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00051-34

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00051-33

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00011-37

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00011-36

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00011-35

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00011-34

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00011-33

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00011-32

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00011-31

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00011-30

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00011-29

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00001-45

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00001-44

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00001-43

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00001-42

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00001-41

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00001-40

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00001-39

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00001-38

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00001-37

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00001-36

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00001-35

MEDITECH SPINE, LLC

2017-10-06

CURE LP - S1-9-00001-34

MEDITECH SPINE, LLC

2017-10-06

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