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
42961–42984 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 2012
GEO
K121705 · BZD
Resmed, Ltd.
Anesthesiology · 137d
Cleared Oct 23, 2012
NUVASIVE SAGE LATERAL PLATE SYSTEM
K121815 · KWQ
Nuvasive, Inc.
Orthopedic · 125d
Cleared Oct 23, 2012
AURICAL HIT
K122028 · ETW
Gn Otometrics
Ear, Nose, Throat · 105d
Cleared Oct 23, 2012
MEDRANGE ELECTROSURGICAL EXPANSION SYSTEM
K122092 · GEI
Medrange Corporation
General & Plastic Surgery · 99d
Cleared Oct 23, 2012
IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM
K122280 · OHT
Cyden Limited
General & Plastic Surgery · 85d
Cleared Oct 23, 2012
CARESTREAM VUE PACS
K122523 · LLZ
Carestream Health, Inc.
Radiology · 64d
Cleared Oct 23, 2012
OSSEOFLEX SB INFLATABLE BONE TAMP
K122533 · NDN
Osseon Therapeutics, Inc.
Orthopedic · 64d
Cleared Oct 23, 2012
ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE
K123109 · GDW
Covidien
General & Plastic Surgery · 19d
Cleared Oct 22, 2012
PHASIX PLUG AND PATCH
K120728 · OWT
C.R. Bard, Inc.
General & Plastic Surgery · 227d
Cleared Oct 22, 2012
XN CAL PF
K120747 · KRX
Streck
Hematology · 224d
Cleared Oct 22, 2012
CPRMETER CPR FEEDBACK DEVICE
K122050 · LIX
Laerdal Medical A/S
Cardiovascular · 102d
Cleared Oct 22, 2012
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS...
K122277 · HRY
Biomet Manufacturing Corp
Orthopedic · 84d
Cleared Oct 22, 2012
DYNASTY BIOFOAM SHELL
K122382 · MBL
Wrightmedicaltechnologyinc
Orthopedic · 77d
Cleared Oct 22, 2012
TRANSTEK WRIST BLOOD PRESSURE MONITOR
K122482 · DXN
Zhongshan Transtek Electronics Co., Ltd.
Cardiovascular · 69d
Cleared Oct 22, 2012
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
K122898 · GAM
Surgical Specialties Corp. Dba Angiotech
General & Plastic Surgery · 31d
Cleared Oct 22, 2012
ATLAS GOLD PTA DILATATION CATHETER
K122984 · LIT
C.R. Bard, Inc.
Cardiovascular · 26d
Cleared Oct 22, 2012
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERS
K123019 · LPH
Zimmer, Inc.
Orthopedic · 24d
Cleared Oct 19, 2012
SYSMEX XN-SERIES
K112605 · GKZ
Sysmex America, Inc.
Hematology · 408d
Cleared Oct 19, 2012
ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K113219 · HSB
Ellipse Technologies, Inc.
Orthopedic · 353d
Cleared Oct 19, 2012
LACRICATH LACRIMAL DUCT CATHETER
K113867 · OKS
Quest Medical, Inc.
Ophthalmic · 294d
Cleared Oct 19, 2012
VENUS FACET SCREW SYSTEM
K120340 · MRW
Apollo Spine, Inc.
Orthopedic · 259d
Cleared Oct 19, 2012
XN CHECK
K120742 · JPK
Streck
Hematology · 221d
Cleared Oct 19, 2012
XN CHECK BF
K120744 · JPK
Streck
Hematology · 221d
Cleared Oct 19, 2012
XN CAL
K120745 · KRX
Streck
Hematology · 221d