Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
68593–68616 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 2004
THERMOTEK Q5
K041646 · FLL
Saat , Ltd.
General Hospital · 35d
Cleared Jul 22, 2004
IMAGENMD
K041671 · KPS
Cardiovascular Imaging Technologies, LLC
Radiology · 31d
Cleared Jul 22, 2004
AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM
K041701 · MQB
Agfa Corp.
Radiology · 30d
Cleared Jul 22, 2004
SUPER REVO HERCULINE SUTURE ANCHOR
K041713 · MBI
Linvatec Corp.
Orthopedic · 29d
Cleared Jul 22, 2004
PTFE FELTS AND PLEDGETS
K041716 · DXZ
Boston Scientific Corp
Cardiovascular · 28d
Cleared Jul 22, 2004
ONCENTRA-VISIR
K041719 · MUJ
Nucletron Corp.
Radiology · 28d
Cleared Jul 22, 2004
ACE CONNECT INTERNAL CONNECTION
K041759 · DZE
Ace Surgical Supply Co., Inc.
Dental · 23d
Cleared Jul 22, 2004
LUNG CAR 1.1
K041807 · OEB
Medicsight
Radiology · 16d
Cleared Jul 22, 2004
GOODKNIGHT 425, MODELM-114500-00
K041819 · BZD
Mallinckrodt Developpement France
Anesthesiology · 16d
Cleared Jul 22, 2004
MAXIMUS OS (OVERDENTURE SYSTEM)
K041938 · DZE
BioHorizons Implant Systems, Inc.
Dental · 3d
Cleared Jul 21, 2004
MAGNETOM ESPREE SYSTEM
K041112 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Jul 21, 2004
DYNACAD V1.0
K041286 · LNH
Mri Devices Corp.
Radiology · 69d
Cleared Jul 21, 2004
MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-AP
K041411 · DXN
Microlife Corp.
Cardiovascular · 55d
Cleared Jul 21, 2004
VIABIL BILIARY ENDOPROSTHESIS
K041423 · FGE
W.L. Gore & Associates, Inc.
Gastroenterology & Urology · 54d
Cleared Jul 21, 2004
MAXCEM
K041474 · EMA
Sybron Dental Specialties, Inc.
Dental · 49d
Cleared Jul 21, 2004
EOCD
K041568 · NFB
Respironics, Inc.
Anesthesiology · 41d
Cleared Jul 21, 2004
ARCHITECT STAT CK-MB IMMUNOASSAY
K041596 · JHX
Fisher Diagnostics
Chemistry · 37d
Cleared Jul 21, 2004
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS...
K041741 · MHX
Philips Medical Systems, Inc.
Cardiovascular · 23d
Cleared Jul 20, 2004
MYO-TRODE SG DISPOSABLE ELECTRODE
K040400 · NUW
Myotronics-Noromed, Inc.
Dental · 154d
Cleared Jul 20, 2004
LATIT FLOW
K040465 · EBF
Ab Ardent
Dental · 148d
Cleared Jul 20, 2004
DOVER ROB-NEL CATHETER
K040897 · KOD
Tyco Healthcare
Gastroenterology & Urology · 105d
Cleared Jul 20, 2004
FERTELL MALE FERTILITY TEST
K041039 · POV
Genosis , Ltd.
Chemistry · 89d
Cleared Jul 20, 2004
ZIMMER ANATOMIC II HIP PROSTHESIS
K041109 · LPH
Zimmer, Inc.
Orthopedic · 83d
Cleared Jul 20, 2004
MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES
K041327 · CAF
Med2000 S.R.L.
Anesthesiology · 63d