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
131113–131136 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 1989
ARGEDENT 88, DENTAL ALLOY FOR PORCELAIN)
K891600 · EJT
Argen Precious Metals, Inc.
Dental · 86d
Cleared Jun 14, 1989
LAMINARIA TENT
K892220 · HDY
Berkeley Medevices
Obstetrics & Gynecology · 72d
Cleared Jun 14, 1989
ORALCHEK SUPER-SOFT BRUSH
K892264 · EFW
Pfizer, Inc.
Dental · 70d
Cleared Jun 14, 1989
KULZER TRANSLUX EC
K892456 · EBZ
Kulzer, Inc.
Dental · 65d
Cleared Jun 14, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892624 · LYY
Sanital Co., Ltd.
General Hospital · 65d
Cleared Jun 14, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892625 · LYY
Hand Care, Inc., Ltd.
General Hospital · 65d
Cleared Jun 14, 1989
PATIENT EXAMINATION GLOVES (POLY)
K892768 · LZA
Promedica Products, Inc.
General Hospital · 64d
Cleared Jun 14, 1989
ARGELITE 76SF+ DENTAL ALLOY
K892910 · EJT
Argen Precious Metals, Inc.
Dental · 55d
Cleared Jun 14, 1989
LATEX PATIENT EXAMINATION GLOVES
K892923 · LYY
Gigantic International Corp.
General Hospital · 62d
Cleared Jun 14, 1989
PATIENT EXAMINATION GLOVES
K892945 · LYY
R.J.M. Precaution Products, Inc.
General Hospital · 63d
Cleared Jun 14, 1989
PATIENT EXAMINATION GLOVES
K892961 · LYY
Viratect, Inc.
General Hospital · 63d
Cleared Jun 14, 1989
LATEX EXAM GLOVES (MFG. BROADLAND RUBBER INDUST.)
K892965 · LYY
Dmp, Inc.
General Hospital · 63d
Cleared Jun 14, 1989
JASONTEX LATEX EXAMINATION GLOVES
K893047 · LYY
Jasontex Co., Ltd.
General Hospital · 62d
Cleared Jun 14, 1989
VINYL EXAM GLOVES (MFG. TOPLAS INDUSTRIAL CO.)
K893098 · LYZ
Jason Co.
General Hospital · 61d
Cleared Jun 14, 1989
LATEX EXAMINATION GLOVES
K893166 · LYY
Gulfwin Holding Sdn. Bhd.
General Hospital · 61d
Cleared Jun 14, 1989
LATEX EXAMINATION GLOVES
K893266 · LYY
Yi-Gang Machinery & Engineering Co.,...
General Hospital · 58d
Cleared Jun 14, 1989
ARGELITE 50 (DENTAL ALLOY FOR PORCELAIN APPLI.)
K893345 · EJT
Argen Precious Metals, Inc.
Dental · 51d
Cleared Jun 14, 1989
ARGENCO 71 TYPE II DENTAL GOLD ALLOY
K893381 · EJT
Argen Precious Metals, Inc.
Dental · 44d
Cleared Jun 14, 1989
ARGENCO 63 TYPE III DENTAL GOLD ALLOY
K893382 · EJT
Argen Precious Metals, Inc.
Dental · 44d
Cleared Jun 14, 1989
ARGENCO 75 TYPE III DENTAL GOLD ALLOY
K893383 · EJT
Argen Precious Metals, Inc.
Dental · 44d
Cleared Jun 14, 1989
ARGENCO 83 TYPE I DENTAL GOLD ALLOY
K893384 · EJT
Argen Precious Metals, Inc.
Dental · 44d
Cleared Jun 14, 1989
ARGENCO 77 TYPE II DENTAL GOLD ALLOY
K893385 · EJT
Argen Precious Metals, Inc.
Dental · 44d
Cleared Jun 14, 1989
ARGENCO 62 TYPE III DENTAL GOLD ALLOY
K893386 · EJT
Argen Precious Metals, Inc.
Dental · 44d
Cleared Jun 14, 1989
ARGENCO 40 TYPE III DENTAL GOLD ALLOY
K893413 · EJT
Argen Precious Metals, Inc.
Dental · 43d