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
68905–68928 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 2004
ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM
K041158 · CAZ
Atrion Medical Products, Inc.
Anesthesiology · 44d
Cleared Jun 16, 2004
PTM SYSTEM
K041335 · EIH
Dentsply International
Dental · 29d
Cleared Jun 16, 2004
XENO NM LIGHT CURED DENTAL ADHESIVE
K041343 · KLE
Dentsply International
Dental · 27d
Cleared Jun 16, 2004
MODIFICATION TO OSSEOTITE NT CERTAIN IMPLANTS
K041402 · DZE
Implant Innovations, Inc.
Dental · 21d
Cleared Jun 16, 2004
HEXAPOD RT COUCHTOP
K041448 · JAI
Medical Intelligence Medizintechnik GmbH
Radiology · 15d
Cleared Jun 15, 2004
LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS
K030831 · GEI
Modern Medical Equipment Mfg., Ltd.
General & Plastic Surgery · 459d
Cleared Jun 15, 2004
MODERN MEDICAL BIPOLAR FORCEPS
K032327 · GEI
Modern Medical Equipment Mfg., Ltd.
General & Plastic Surgery · 323d
Cleared Jun 15, 2004
OLINDA/EXM
K033960 · IYX
Vanderbilt University
Radiology · 176d
Cleared Jun 15, 2004
RELIANT LASER SYSTEM II
K040617 · GEX
Reliant Technologies, Inc.
General & Plastic Surgery · 98d
Cleared Jun 15, 2004
SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS
K040701 · HWC
Synthes (Usa)
Orthopedic · 90d
Cleared Jun 15, 2004
PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16
K040835 · FTM
Pm Devices, Inc.
General & Plastic Surgery · 76d
Cleared Jun 15, 2004
S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC)...
K040900 · LPL
Optical Connection, Inc.
Ophthalmic · 70d
Cleared Jun 15, 2004
MEDTRONIC PS MEDICAL STRATA VALVE
K040943 · JXG
Medtronic Neurosurgery
Neurology · 64d
Cleared Jun 15, 2004
STAY-PUT IMPREGNATED
K041023 · MVL
Coltene/Whaledent GmbH & Co. KG
Dental · 56d
Cleared Jun 15, 2004
DIGORA OPTIME (OR DIGORA ONTIME)
K041050 · MUH
Soredex Palodex Group OY
Radiology · 54d
Cleared Jun 15, 2004
GE DISCOVERY ST SYSTEM
K041220 · KPS
GE Medical Systems
Radiology · 36d
Cleared Jun 15, 2004
BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER
K041331 · GDW
Biopsy Sciences, LLC
General & Plastic Surgery · 27d
Cleared Jun 14, 2004
QUEST DIAGNOSTICS HAIRCHECK-DT (THC)
K040257 · LDJ
Quest Diagnostics, Inc.
Toxicology · 131d
Cleared Jun 14, 2004
ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS
K040425 · NBC
Bayer Healthcare, LLC
Chemistry · 117d
Cleared Jun 14, 2004
CONTOUR HA COATED RECONSTRUCTION RING
K040680 · MEH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Jun 14, 2004
HILUX LEDMAX 3
K040956 · EBZ
First Medical Infection Control...
Dental · 62d
Cleared Jun 14, 2004
STRYKER BIOZIP SUTURE ANCHOR SYSTEM
K041305 · MAI
Stryker Endoscopy
Orthopedic · 28d
Cleared Jun 14, 2004
MODIFICATION TO STRYKER XCEL ANCHOR SYSTEM
K041307 · MAI
Stryker Endoscopy
Orthopedic · 28d
Cleared Jun 14, 2004
STRYKER WEDGE SUTURE ANCHOR SYSTEM
K041310 · MBI
Stryker Endoscopy
Orthopedic · 28d