FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
130801–130824 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 1989
VINYL EXAMINATION GLOVES
K893102 · LYY
Samson Taiwan Corp.
General Hospital · 91d
Cleared Jul 14, 1989
HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX
K893133 · KLK
Mennen Medical, Inc.
Anesthesiology · 80d
Cleared Jul 14, 1989
LATEX EXAMINATION GLOVES
K893176 · LYY
Makintech Corp.
General Hospital · 88d
Cleared Jul 14, 1989
LATEX EXAMINATION GLOVES
K893178 · LYY
Intl. Marketing Assoc. Corp.
General Hospital · 88d
Cleared Jul 14, 1989
SENSIFIT(R) LATEX EXAMINATION GLOVES
K893180 · LYY
Inter-Asia Co., Inc.
General Hospital · 88d
Cleared Jul 14, 1989
LATEX EXAMINATION GLOVES
K893184 · LYY
Green Cross Medical Supplies Corp.
General Hospital · 88d
Cleared Jul 14, 1989
MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM
K893232 · DSK
Camino Laboratories, Inc.
Cardiovascular · 77d
Cleared Jul 14, 1989
BION EBV-M (VCA) TEST SYSTEM
K893240 · LJN
Bion Ent., Ltd.
Microbiology · 77d
Cleared Jul 14, 1989
LATEX EXAM GLOVES
K893241 · LYY
Semodal Jaya Sdn. Bhd.
General Hospital · 77d
Cleared Jul 14, 1989
VINYL EXAMINATION GLOVES
K893261 · LYZ
Clear Window Industrial, Ltd.
General Hospital · 88d
Cleared Jul 14, 1989
LATEX EXAMINATION GLOVES
K893284 · LYY
Aliga Export Sdn Bhd
General Hospital · 91d
Cleared Jul 14, 1989
LATEX EXAMINATION GLOVES
K893309 · LYY
P.T. Delta Waru Rubber Industry
General Hospital · 87d
Cleared Jul 14, 1989
LATEX EXAMINATION GLOVES
K893331 · LYY
P.T. Kencana Ronasakti Prima
General Hospital · 86d
Cleared Jul 14, 1989
LATEX EXAMINATION GLOVES
K893333 · LYY
Ever Shine Industrial , Ltd.
General Hospital · 86d
Cleared Jul 14, 1989
LATEX EXAMINATION GLOVES
K893347 · LYY
Changzhou Foreign Economic Technical...
General Hospital · 84d
Cleared Jul 14, 1989
LATEX EXAMINATION GLOVES
K893352 · LYY
Hua Shu-Yee Industrial Co., Ltd.
General Hospital · 84d
Cleared Jul 14, 1989
LATEX EXAMINATION GLOVES
K893353 · LYY
Chorng Rong Industrial Co., Ltd.
General Hospital · 84d
Cleared Jul 14, 1989
VITATRACE
K893425 · DRX
Lectec Corp.
Cardiovascular · 73d
Cleared Jul 14, 1989
MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT
K893436 · DWS
Pioneering Technologies, Inc.
Cardiovascular · 72d
Cleared Jul 14, 1989
CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST)
K893466 · LKQ
Immuno Concepts, Inc.
Microbiology · 72d
Cleared Jul 14, 1989
CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST)
K893467 · LIN
Immuno Concepts, Inc.
Microbiology · 72d
Cleared Jul 14, 1989
CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST)
K893468 · LIN
Immuno Concepts, Inc.
Microbiology · 72d
Cleared Jul 14, 1989
CRYSTAR(TM) ANTI-GREENING LIQUID
K893481 · ELL
Shofu Dental Corp.
Dental · 71d
Cleared Jul 14, 1989
BONDABLE RETAINER AND SPACE MAINTAINER
K893483 · EJF
American Orthodontics
Dental · 71d