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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
48865–48888 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 03, 2010
STELLATE GRIDVIEW
K100126 · OLX
Excel-Tech Ltd. (Xltek)
Radiology · 318d
Cleared Dec 03, 2010
KLASSIC HD HIP SYSTEM
K100445 · LPH
Total Joint Orthopedics, Inc.
Orthopedic · 289d
Cleared Dec 03, 2010
ANYPLUS PEEK CAGES
K100516 · OVD
GS Medical Co., Ltd.
Orthopedic · 283d
Cleared Dec 03, 2010
BOSWORTH AIR POLISHER
K100731 · EFB
Harry J. Bosworth Co.
Dental · 263d
Cleared Dec 03, 2010
BIOPRO POLAR HEAD
K100761 · KWY
Biopro, Inc.
Orthopedic · 261d
Cleared Dec 03, 2010
BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES
K100785 · EBW
Bonart Co., Ltd.
Dental · 259d
Cleared Dec 03, 2010
PACENTRIC CONNECT, TRAVELER AND WEB
K100837 · LLZ
Fimreite Software AS
Radiology · 254d
Cleared Dec 03, 2010
SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS
K101224 · DWL
Griffiths and Nielsen, Ltd.
General Hospital · 214d
Cleared Dec 03, 2010
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM...
K101229 · LPH
Zimmer, Inc.
Orthopedic · 214d
Cleared Dec 03, 2010
PREMIO 10 MOXA
K101267 · ILY
Sedatelec
Physical Medicine · 212d
Cleared Dec 03, 2010
SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR...
K101690 · LKD
Sentec AG
Anesthesiology · 170d
Cleared Dec 03, 2010
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS
K101730 · KWZ
Zimmer, Inc.
Orthopedic · 168d
Cleared Dec 03, 2010
MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079
K101835 · HBW
Porex Surgical, Inc.
Neurology · 155d
Cleared Dec 03, 2010
HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM
K101907 · CAC
Haemonetics Corp.
Anesthesiology · 148d
Cleared Dec 03, 2010
ENCODE PATIENT SPECIFIC ABUTMENT
K102209 · NHA
Biomet 3i, Inc.
Dental · 120d
Cleared Dec 03, 2010
RELIANCE ENDOSCOPE PROCESSING SYSTEM
K102244 · NZA
STERIS Corporation
General Hospital · 116d
Cleared Dec 03, 2010
DMP PIT & FISSURE SEALANT
K102252 · EBC
Dmp, Ltd.
Dental · 115d
Cleared Dec 03, 2010
HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P
K102305 · EIH
Hass Corp.
Dental · 109d
Cleared Dec 03, 2010
PATRIOT TRANSCONTINENTAL M SPACERS
K102313 · MAX
Globus Medical, Inc.
Orthopedic · 109d
Cleared Dec 03, 2010
SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT
K102382 · NHA
Cendres & Metaux SA
Dental · 102d
Cleared Dec 03, 2010
NEXSTAT (TM) TOPICAL HEMOSTAT POWDER
K102459 · QSY
Hemostasis, LLC
General & Plastic Surgery · 98d
Cleared Dec 03, 2010
FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS
K102607 · LLL
Biomedical Diagnostics (Bmd) SA
Immunology · 84d
Cleared Dec 03, 2010
VERTEX RAPID SIMPLIFIED
K102654 · EBI
Vertex-Dental B.V.
Dental · 80d
Cleared Dec 03, 2010
MERETE LOCKING BONE PLATE SYSTEM II
K102688 · KTT
Merete Medical GmbH
Orthopedic · 77d