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
46945–46968 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 2011
NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM
K111866 · KWQ
Nuvasive, Inc.
Orthopedic · 22d
Cleared Jul 21, 2011
ETURN SPINAL IMPLANT MODEL ETURN XX-12
K100305 · MAX
Icotec
Orthopedic · 533d
Cleared Jul 21, 2011
VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE
K101453 · NPL
Obi Biologics, Inc.
Dental · 422d
Cleared Jul 21, 2011
DSC/ALF SPINAL SYSTEM
K101886 · MQP
Sintea Plastek, LLC
Orthopedic · 380d
Cleared Jul 21, 2011
INFUSION SET FOR POWERPICC SOLO 2 CATHETER
K102405 · FPA
C.R. Bard, Inc.
General Hospital · 331d
Cleared Jul 21, 2011
COREN TOTAL HIP SYSTEM
K103431 · LPH
Corentec Co., Ltd.
Orthopedic · 240d
Cleared CT Jul 21, 2011
SLEEPMINDER BREATHING FREQUENCY INDICATOR
K103631 · BZQ
Biancamed Limited
Anesthesiology · 220d
Cleared Jul 21, 2011
GENESYS SPINE TILOCK SYSTEM
K103671 · NKB
Genesys Spine
Orthopedic · 217d
Cleared Jul 21, 2011
DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809
K103831 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 203d
Cleared Jul 21, 2011
EXPLOR RADIAL HEAD PLATING SYSTEM
K110201 · HRS
Biomet, Inc.
Orthopedic · 178d
Cleared Jul 21, 2011
COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEM
K110320 · HRS
Biomet Manufacturing Corp
Orthopedic · 168d
Cleared Jul 21, 2011
POWDERED VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR (NON-COLORED)
K110966 · LYZ
Ppp Medical and Safety Products...
General Hospital · 106d
Cleared Jul 21, 2011
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K110970 · LYZ
Ppp Medical and Safety Products...
General Hospital · 106d
Cleared Jul 21, 2011
CI-SNAP WOUND CARE SYSTEM
K111006 · OKO
Spiracur, Inc.
General & Plastic Surgery · 101d
Cleared Jul 21, 2011
V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT
K111280 · OMP
Kci USA, Inc.
General & Plastic Surgery · 76d
Cleared Jul 21, 2011
REXIOUS SPINAL FIXATION SYSTEM
K111362 · MNH
Dio Medical Co., Ltd.
Orthopedic · 66d
Cleared Jul 21, 2011
METASURG DIGIFUSE IMPLANT
K111536 · HWC
Metasurg
Orthopedic · 49d
Cleared Jul 21, 2011
ELECSYS T3 CALCHECK 5
K111552 · JJX
Roche Diagnostics
Chemistry · 48d
Cleared Jul 21, 2011
EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
K111750 · DQY
Angioslide, Ltd.
Cardiovascular · 29d
Cleared Jul 21, 2011
SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEM
K111801 · OUR
Zyga Technology, Inc.
Orthopedic · 24d
Cleared Jul 20, 2011
AVIE A1C TEST SYSTEM
K093548 · LCP
Mec Dynamics Corp
Chemistry · 610d
Cleared Jul 20, 2011
CRAG LATERAL FLOW ASSAY (CRAG LFA)
K102286 · GMD
Immuno-Mycologics, Inc.
Microbiology · 342d
Cleared Jul 20, 2011
HEMI IMPLANT
K102401 · KWD
Vilex, Inc.
Orthopedic · 330d
Cleared Jul 20, 2011
BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF
K103745 · LFD
Glaxosmithkline Consumer Healthcare...
Dental · 209d