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
122929–122952 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 07, 1991
LARES 757 WORKHORSE HIGHSPEED HANDPIECE
K905541 · EFB
Lares Research, Inc.
Dental · 86d
Cleared Mar 07, 1991
COMPRINET, COMTESSE AND BELLAVAR STOCKINGS
K905631 · DWL
Jobst Institute, Inc.
General Hospital · 80d
Cleared Mar 07, 1991
ZIMMER CERAMIC FEMORAL HEADS
K905739 · LZO
Zimmer, Inc.
Orthopedic · 73d
Cleared Mar 07, 1991
MAMEX DC AMI SL12/MG15
K905748 · IZH
Soredex, Inc.
Radiology · 71d
Cleared Mar 07, 1991
AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER*
K910586 · GDT
United States Surgical, A Division of...
General & Plastic Surgery · 24d
Cleared Mar 07, 1991
SUNTEX STERILE EXAM GLOVES
K910631 · LYY
P.T. Latexindo Prautama
General Hospital · 22d
Cleared Mar 07, 1991
BOSTON(R) BRAND LATEX EXAM GLOVES/HYPOALLERGENIC
K910660 · LYY
Boston Medical Corp.
General Hospital · 21d
Cleared Mar 07, 1991
AM GLOVES STERILE VINYL EXAMINATION
K910774 · LYZ
Am Gloves Co., Ltd.
General Hospital · 13d
Cleared Mar 07, 1991
JM GLOVES STERILE VINYL EXAMINATION
K910775 · LYZ
Jm Gloves Co., Ltd.
General Hospital · 13d
Cleared Mar 07, 1991
COMPANION SPEECH AID, MODEL 432
K910796 · ILQ
Companion Products Intl.
Physical Medicine · 9d
Cleared Mar 07, 1991
COMPANION SPEECH AID, MODEL 160
K910819 · ILQ
Companion Products Intl.
Physical Medicine · 9d
Cleared Mar 07, 1991
VPW 2877E6 X-RAY POWER SUPPLY
K910820 · IZO
Varian Canada, Inc.
Radiology · 10d
Cleared Mar 06, 1991
POLYURETHANE CONDOM
K902936 · HIS
Apex Medical Technologies, Inc.
Obstetrics & Gynecology · 246d
Cleared Mar 06, 1991
VIDEO ENDOSCOPE, RIGID
K903339 · HET
Medical Dynamics, Inc.
Obstetrics & Gynecology · 224d
Cleared Mar 06, 1991
CONVATEC ABSORBENT BANDAGE
K904233 · EXE
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 182d
Cleared Mar 06, 1991
INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER
K904265 · FZW
Inamed Development Co.
General & Plastic Surgery · 169d
Cleared Mar 06, 1991
OMIBAND
K904445 · KGX
Omikron Scientific, Ltd.
General & Plastic Surgery · 159d
Cleared Mar 06, 1991
CRI CYNOSAR CATHETER
K904785 · DRA
Catheter Research C/O Burditt, Bowles...
Cardiovascular · 135d
Cleared Mar 06, 1991
ELLIPSE PUNCH
K904869 · LRY
Kramer Const
General & Plastic Surgery · 128d
Cleared Mar 06, 1991
DISPOSABLE YANKAUER SUCTION TUBE
K904881 · GEA
Pilling Medical S.A.
General & Plastic Surgery · 133d
Cleared Mar 06, 1991
LAPAROTOMY SPONGES
K905135 · GDY
American Healthcare Corp.
General & Plastic Surgery · 111d
Cleared Mar 06, 1991
GAUZE SPONGES, INTERNAL AND EXTERNAL
K905136 · EFQ
American Healthcare Corp.
General & Plastic Surgery · 111d
Cleared Mar 06, 1991
NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY
K905181 · EZN
Meadox Surgimed, Inc.
Gastroenterology & Urology · 107d
Cleared Mar 06, 1991
E-20 RAPID CUFF INFLATOR
K905367 · DXN
D. E. Hokanson, Inc.
Cardiovascular · 99d