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

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176,076 results
158041–158064 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 1983
BATH TUB SEAT & BATH BOARD
K830851 · ILC
Lic-Orthion
Physical Medicine · 19d
Cleared Apr 05, 1983
SHOWER STOOL W/HANDLES
K830852 · ILS
Lic-Orthion
Physical Medicine · 19d
Cleared Apr 05, 1983
COLLAPSABLE LAVATORY SEAT HEIGHTENER
K830854 · ILC
Lic-Orthion
Physical Medicine · 19d
Cleared Apr 05, 1983
SESAM TREATMENT TABLE
K830855 · INQ
Lic-Orthion
Physical Medicine · 19d
Cleared Apr 05, 1983
MANOMETER SET C.V.P. #S 298/299
K830910 · KRK
Exco, Inc.
Cardiovascular · 15d
Cleared Apr 04, 1983
NOVO BMC LAB 22A BONE MINERAL CONTENT DETERMINATION IN THE AXIAL SKELETON
K828574
Novo Diagnostic Systems
Radiology · 35d
Cleared Apr 04, 1983
BIOSOUND SURGISCAN, ULTRASOUND IMAGING SYSTEM
K837063
Biosound, Inc.
Radiology · 77d
Cleared Apr 04, 1983
BRITT SURGICAL PHOTOCOAGULATOR SYSTEM
K837200
Britt Corp., Inc.
Radiology · 70d
Cleared Apr 04, 1983
MULTI-USER IMAGING AND ACQUISITION TERMINALS
K837213
Computer Design & Applications, Inc.
Radiology · 61d
Cleared Apr 04, 1983
MODEL XA-15 LASER SYSTEM FOR SURGERY
K837216
Xanar, Inc.
Radiology · 35d
Cleared Apr 04, 1983
MODEL 920 ARGON LASER SYSTEM
K837235
Coherent Radiation Laboratories
Radiology · 34d
Cleared Apr 02, 1983
OXYMIZER
K830009 · NFB
Chad Therapeutics, Inc.
Anesthesiology · 89d
Cleared Apr 01, 1983
AUTOFOCUS PROBE FOR USE WITH ULTRASOUND AUTOSECTOR SYSTEM
K837046
Technicare Corp.
Radiology · 81d
Cleared Apr 01, 1983
EMINEX LS-8 SYSTEM
K837181
Elscint, Inc.
Radiology · 44d
Cleared Mar 31, 1983
MEDICATED ADHESIVE STRIP
K823057
Cederroth, Inc. USA
General & Plastic Surgery · 164d
Cleared Mar 31, 1983
ORAL SPONGE
K823136
Amisplint
Dental · 157d
Cleared Mar 31, 1983
EMG BIOFEEDBACK DEVICE
K823511 · HCC
Nemectron Medical, Inc.
Neurology · 122d
Cleared Mar 31, 1983
SUBCLAVIAN INSERTION KIT
K823527 · FMF
Cunningham Woodland, Inc.
General Hospital · 121d
Cleared Mar 31, 1983
MEDCARE SUTURE REMOVAL TRAYS
K823854 · FSM
Medcare Products
General & Plastic Surgery · 99d
Cleared Mar 31, 1983
MODEL ZY PACEMAKER LEAD-VARIOUS
K823890 · DTB
Oscor, Inc.
Cardiovascular · 94d
Cleared Mar 31, 1983
MODEL KY PACEMAKER LEAD - VARIOUS
K823891 · DTB
Oscor, Inc.
Cardiovascular · 94d
Cleared Mar 31, 1983
DIGITAL SUBTRACTION ANGIOGRAPHY CONVEN-
K830025 · DQO
Medrad/Technology For People
Cardiovascular · 86d
Cleared Mar 31, 1983
SIRECUST 400
K830029 · DSI
Analogic Corp.
Cardiovascular · 86d
Cleared Mar 31, 1983
END TIDAL CO2 ANALYZER #411
K830253
Andros Incorporated
Cardiovascular · 65d