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
123841–123864 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 1990
QUALITONE ITE GENESIS
K904731 · ESD
Qualitone
Ear, Nose, Throat · 61d
Cleared Dec 17, 1990
OSADA ENDEX
K904742 · LQY
Osada Electric Co., Ltd.
Dental · 60d
Cleared Dec 17, 1990
CRI STEERABLE CATHETER CONTROL SYSTEM
K904787 · DXX
Catheter Research C/O Burditt, Bowles...
Cardiovascular · 55d
Cleared Dec 17, 1990
MEWISSEN CATHETER
K904788 · DQO
Boston Scientific Corp
Cardiovascular · 55d
Cleared Dec 17, 1990
DENTAL VACUUM INJECTION TRAY
K904914 · KMT
The Lebanon Vac-Tray Corp.
Dental · 47d
Cleared Dec 17, 1990
TRANSLUMINAL ENDARTERECTOMY DEVICE
K904944 · DWX
Baxter Healthcare Corp
Cardiovascular · 46d
Cleared Dec 17, 1990
PSG HEMOSTATIC CONTROL VALVE
K904959 · DQO
Peripheral Systems Group
Cardiovascular · 42d
Cleared Dec 17, 1990
ORTHO CMV-M ANTIBODY ELISA TEST
K905077 · LFZ
Ortho Diagnostic Systems, Inc.
Microbiology · 34d
Cleared Dec 17, 1990
ORTHO CMV-G ANTIBODY ELISA TEST
K905078 · LFZ
Ortho Diagnostic Systems, Inc.
Microbiology · 34d
Cleared Dec 17, 1990
SAF FIXATIVE
K905120 · LIO
Gibson Laboratories, Inc.
Microbiology · 33d
Cleared Dec 17, 1990
DW 235
K905205 · EJJ
Ivoclar North America, Inc.
Dental · 27d
Cleared Dec 17, 1990
MONOBOND S
K905220 · EBF
Ivoclar North America, Inc.
Dental · 27d
Cleared Dec 17, 1990
SPECIAL BOND II
K905221 · EBF
Ivoclar North America, Inc.
Dental · 27d
Cleared Dec 17, 1990
SCRIBBON
K905382 · JES
Varnum Corp.
Dental · 18d
Cleared Dec 14, 1990
3M IGG FASTLYME(TM) TEST
K895713 · LSR
3M Company
Microbiology · 445d
Cleared Dec 14, 1990
NORTA SILICONE ELASTOMER COATED LATEX BALLOON CATH
K900509 · KOD
Medical Latex Corp.
Gastroenterology & Urology · 315d
Cleared Dec 14, 1990
AVI MODEL 4206 MANIFOLD CHECKVALVE IV ADMIN. SET
K902858 · FPA
3M Avi, Inc.
General Hospital · 168d
Cleared Dec 14, 1990
HARVARD/LTE LABORATORY STEAM STERILIZER AUTOCLAVE
K903614 · FLE
Harvard Apparatus, Inc.
General Hospital · 127d
Cleared Dec 14, 1990
CAP-AID
K904107 · FMI
Nda Systems
General Hospital · 99d
Cleared Dec 14, 1990
MODEL GLASE 210 HOLMIUM LASER SYSTEM
K904248 · HGF
Charles L. Rose and Co., Inc.
Obstetrics & Gynecology · 88d
Cleared Dec 14, 1990
KRONNER MANIPUJECTOR
K904473 · HES
Unimar, Inc.
Obstetrics & Gynecology · 74d
Cleared Dec 14, 1990
SUPPORT RING
K904485 · LKY
Numedtec, Inc.
Gastroenterology & Urology · 73d
Cleared Dec 14, 1990
SUPPORT PUMP
K904486 · LKY
Numedtec, Inc.
Gastroenterology & Urology · 73d
Cleared Dec 14, 1990
SAFE SYTE I.V. CATHETER PLACEMENT UNIT
K904648 · FOZ
Deseret Medical, Inc.
General Hospital · 64d