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

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175,820 results
46801–46824 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 2011
SAPPHIRE
K103657 · LOX
Orbusneich Medical, Inc.
Cardiovascular · 237d
Cleared Aug 09, 2011
OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER
K110293 · NVP
Respironics New Jersey, Inc.
Anesthesiology · 189d
Cleared Aug 09, 2011
COLLACARE DENTAL
K110388 · KGN
Innocoll Pharmaceuticals, Ltd.
General & Plastic Surgery · 180d
Cleared Aug 09, 2011
CRESCENT (R) SPINAL SYSTEM TITANIUM
K110543 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 165d
Cleared Aug 09, 2011
SPEEDLOCK KNOTLESS FIXATION DEVICE
K111044 · MBI
ArthroCare Corporation
Orthopedic · 116d
Cleared Aug 09, 2011
METASURG SUBTALAR IMPLANT
K111265 · HWC
Metasurg
Orthopedic · 97d
Cleared Aug 09, 2011
NAVIAID(TM) BGC DEVICE
K111760 · ODC
Smart Medical Systems , Ltd.
Gastroenterology & Urology · 48d
Cleared Aug 08, 2011
CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES
K111047 · OWN
Mauna Kea Technologies, Inc.
General & Plastic Surgery · 115d
Cleared Aug 08, 2011
INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED ABUTMENTS
K111199 · NHA
Intra-Lock International, Inc.
Dental · 102d
Cleared Aug 08, 2011
ANTLIA III WOUND TREATMENT SYSTEM
K111333 · OMP
Innovative Therapies, Inc.
General & Plastic Surgery · 88d
Cleared Aug 08, 2011
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
K111540 · HRS
Synthes (Usa)
Orthopedic · 67d
Cleared Aug 08, 2011
ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHOR
K111590 · MBI
Rog Sports Medicine, Inc.
Orthopedic · 62d
Cleared Aug 08, 2011
Y-KNOT ALL-SUTURE ANCHOR MODEL HF13
K111779 · MBI
Conmed Linvatec
Orthopedic · 45d
Cleared Aug 08, 2011
T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP
K112059 · HSB
Stryker
Orthopedic · 20d
Cleared Aug 05, 2011
PERIMETER C SPINAL SYSTEM
K100967 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 484d
Cleared Aug 05, 2011
SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY
K101517 · IZL
Sedecal., Sa.
Radiology · 429d
Cleared Aug 05, 2011
SURGICAL FACE MASK
K110027 · FXX
Angeline Group , Ltd.
General Hospital · 212d
Cleared Aug 05, 2011
BRAINLAB TRAUMA
K110204 · OLO
Brainlab AG
Orthopedic · 193d
Cleared Aug 05, 2011
FREEWAY COMFORT BITE GUARD
K110468 · MQC
Randmark Dental Products, LLC
Dental · 169d
Cleared Aug 05, 2011
HEADWAY 27 MICROCATHETER
K110813 · DQY
MicroVention, Inc.
Cardiovascular · 134d
Cleared Aug 05, 2011
ORTHOPEDIATRICS BLADE PLATE SYSTEM
K110959 · HRS
OrthoPediatrics Corp.
Orthopedic · 122d
Cleared Aug 05, 2011
IBIS EXPLORER AND MARKUP SOFTWARE
K111319 · LLZ
Medqia
Radiology · 87d
Cleared Aug 05, 2011
ST AIA-PACK DHEA-S CALIBRATOR SET
K111762 · JIT
Tosoh Bioscience, Inc.
Chemistry · 43d
Cleared Aug 05, 2011
GLIASITE RTS
K111931 · KXK
Isoray Medical, Inc.
Radiology · 28d