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
59401–59424 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 08, 2007
STERILIZATION POUCH WITH INDICATORS
K062704 · FRG
Winner Industries (Shenzhen) Co., Ltd.
General Hospital · 270d
Cleared Jun 08, 2007
PORTACLAMP FLEX
K070380 · DXC
Cardio Life Research, S.A.
Cardiovascular · 120d
Cleared Jun 08, 2007
SYNAPSE SYSTEM
K070573 · MNI
Synthes Spine Co.Lp
Orthopedic · 100d
Cleared Jun 08, 2007
HYPERTHERMIA PUMP
K070654 · LGZ
Belmont Instrument Corp.
General Hospital · 91d
Cleared Jun 08, 2007
ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)
K070810 · LGS
Biokit, S.A.
Toxicology · 74d
Cleared Jun 08, 2007
MASIMO PATIENT SAFETY NET
K071047 · MSX
Masimo Corporation
Cardiovascular · 56d
Cleared Jun 08, 2007
LMS-LIVER
K071241 · LLZ
Median Technologies
Radiology · 36d
Cleared Jun 08, 2007
SYNGO CT ONCOLOGY SOFTWARE PACKAGE
K071310 · JAK
Siemens AG
Radiology · 30d
Cleared Jun 08, 2007
OPTICAL GUIDANCE PLATFORM
K071360 · IYE
Varian Medical Systems, Inc.
Radiology · 24d
Cleared Jun 08, 2007
X3C 1600 PLUS DIGITAL RADIOGRAPHIC SYSTEM
K071402 · KPR
Imaging Dynamics Company , Ltd.
Radiology · 18d
Cleared Jun 08, 2007
X3C 1590 DIGITAL RADIOGRAPHIC SYSTEM
K071409 · KPR
Imaging Dynamics Company , Ltd.
Radiology · 18d
Cleared Jun 07, 2007
ARTELON STT SPACER
K061956 · KYI
Artimplant AB
Orthopedic · 331d
Cleared Jun 07, 2007
CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
K062541 · LPL
Innova Vision, Inc.
Ophthalmic · 281d
Cleared Jun 07, 2007
PAJUNKS EPILONG SET PEDIATRIC
K062902 · CAZ
PAJUNK GmbH Medizintechnologie
Anesthesiology · 253d
Cleared Jun 07, 2007
HEALTH CHECK KIOSK
K063008 · DXN
Xperex Corporation
Cardiovascular · 248d
Cleared Jun 07, 2007
OPTECURE
K063685 · MBP
Exactech, Inc.
Orthopedic · 177d
Cleared Jun 07, 2007
V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000
K063692 · OMP
Kci USA, Inc.
General & Plastic Surgery · 176d
Cleared Jun 07, 2007
V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766
K063740 · OMP
Kci USA, Inc.
General & Plastic Surgery · 171d
Cleared Jun 07, 2007
EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01
K070320 · KDI
Edwards Lifesciences Services GmbH
Gastroenterology & Urology · 125d
Cleared Jun 07, 2007
KD-525E FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K070395 · DXN
Kodon(Tianjin)Electronic&Electrical...
Cardiovascular · 118d
Cleared Jun 07, 2007
ZIMMER PATELLOFEMORAL JOINT PROSTHESIS
K070695 · KRR
Zimmer, Inc.
Orthopedic · 86d
Cleared Jun 07, 2007
FUTURABOND DC/SINGLE DOSE
K070723 · KLE
Voco GmbH
Dental · 84d
Cleared Jun 07, 2007
POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE
K070760 · LYY
Derma Care Plus Products, LLC
General Hospital · 79d
Cleared Jun 07, 2007
ULCELOOCIN ORAL ULCER PATCH
K070842 · OLR
Sunshine International Group, Inc.
General & Plastic Surgery · 72d