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
67417–67440 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 23, 2004
BICONITE SURFACE TREATMENT
K031568 · DZE
Bicon, Inc.
Dental · 553d
Cleared Nov 23, 2004
TONO-PEN TONOMETER TIP COVER
K033146 · HKY
Tra & Accessories
Ophthalmic · 420d
Cleared Nov 23, 2004
RANDOX CANNABINOIDS ASSSAY
K041142 · LDJ
Randox Laboratories, Ltd.
Toxicology · 207d
Cleared Nov 23, 2004
COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL...
K041388 · GZJ
Biomedical Life Systems, Inc.
Neurology · 182d
Cleared Nov 23, 2004
IMPACT TEST SYSTEM
K041746 · DJG
Lifepoint,Inc
Toxicology · 147d
Cleared Nov 23, 2004
FLOWCARE SYSTEM
K041882 · GKZ
Pointcare Technologies, Inc.
Hematology · 134d
Cleared Nov 23, 2004
HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278
K041926 · JIX
Diagnostic Chemicals , Ltd.
Chemistry · 127d
Cleared Nov 23, 2004
LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40
K041927 · MRR
Diagnostic Chemicals , Ltd.
Chemistry · 127d
Cleared Nov 23, 2004
HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B
K041928 · LBS
Diagnostic Chemicals , Ltd.
Chemistry · 127d
Cleared Nov 23, 2004
REPROCESSED DIAMOND BURS
K041978 · NLN
Alliance Medical Corp.
Neurology · 123d
Cleared Nov 23, 2004
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
K042544 · KWQ
Depuy Spine, Inc.
Orthopedic · 64d
Cleared Nov 23, 2004
UNI-THREAD SPINAL SYSTEM
K042640 · MNH
Spine Vision, Inc.
Orthopedic · 57d
Cleared Nov 23, 2004
SMART BITEBLOC
K042665 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 55d
Cleared Nov 23, 2004
SILHOUETTE SPINAL FIXATION SYSTEM
K042702 · NKB
Zimmer Spine, Inc.
Orthopedic · 54d
Cleared Nov 23, 2004
ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS
K042773 · HIL
Rostam , Ltd.
Obstetrics & Gynecology · 49d
Cleared Nov 23, 2004
RONDOFLEX PLUS 360
K042872 · KOJ
Kavo America Corporation
Dental · 36d
Cleared Nov 23, 2004
SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT
K042883 · JWH
Howmedica Osteonics Corp.
Orthopedic · 35d
Cleared Nov 23, 2004
MODIFICATION TO SYNTHES CRANIAL PLATES
K042987 · JEY
Synthes (Usa)
Dental · 25d
Cleared Nov 23, 2004
THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER...
K043061 · KWS
Zimmer Trabecular
Orthopedic · 18d
Cleared Nov 23, 2004
THE TOSCA ANTERIOR CERVICAL PLATE SYSTEM
K043082 · KWQ
Signus Medizintechnik GmbH
Orthopedic · 15d
Cleared Nov 23, 2004
ROCHE DIAGNOSTICS ELECSYS AFP CALSET II
K043095 · JIT
Roche Diagnostics Corp.
Immunology · 14d
Cleared Nov 22, 2004
PERFECTA FEMORAL STEM
K031402 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 567d
Cleared Nov 22, 2004
VIZILITE-BLUE ORAL EXAM KIT
K033033 · EAZ
Trylon Corp.
Dental · 423d
Cleared Nov 22, 2004
STATUS FIRST STREP A
K040708 · GTY
Princeton BioMeditech Corp.
Microbiology · 249d