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
58945–58968 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 2007
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
K071873 · MUJ
Varian Medical Systems, Inc.
Radiology · 34d
Cleared Aug 09, 2007
BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS...
K071884 · MNW
Jawon Medical Co., Ltd.
Gastroenterology & Urology · 31d
Cleared Aug 09, 2007
ACUMED SMALL BONE LOCKING SYSTEM II
K071944 · HSB
Acumed, LLC
Orthopedic · 27d
Cleared Aug 08, 2007
TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS
K063086 · DDG
Thermo Electron OY
Immunology · 302d
Cleared Aug 08, 2007
FB-100U SERIES DIGITAL BLOOD PRESSURE MONITOR
K070209 · DXN
Fego Precision Industrial Co;, Ltd.
Cardiovascular · 198d
Cleared Aug 08, 2007
LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM
K070341 · KWP
Ldr Spine USA
Orthopedic · 183d
Cleared Aug 08, 2007
MISSION OLYMPUS AU ISE CALIBRATORS
K071039 · JIT
Diamond Diagnostics, Inc.
Chemistry · 118d
Cleared Aug 08, 2007
N LATEX RF KIT
K071247 · DHR
Dade Behring, Inc.
Immunology · 96d
Cleared Aug 08, 2007
HF JUNIOR HEMOFILTER
K071298 · KDI
Minntech Corp.
Gastroenterology & Urology · 91d
Cleared Aug 08, 2007
NUVASIVE HELIX ACP SYSTEM
K071329 · KWQ
Nuvasive, Inc.
Orthopedic · 89d
Cleared Aug 08, 2007
MEDPOR ATTRACTOR IMPLANT
K071335 · HPZ
Porex Surgical, Inc.
Ophthalmic · 89d
Cleared Aug 08, 2007
DIGITAL PULSE OXIMETER, MODEL 7500FO
K071415 · DQA
Nonin Medical, Inc.
Anesthesiology · 79d
Cleared Aug 08, 2007
BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM
K071509 · MNS
Respironics Inc., Sleep & Home...
Anesthesiology · 65d
Cleared Aug 08, 2007
SBI TITANIUM THREADED PIN
K071540 · JDW
Small Bone Innovations, Inc.
Orthopedic · 64d
Cleared Aug 08, 2007
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
K071563 · HRS
Smith & Nephew, Inc.
Orthopedic · 62d
Cleared Aug 08, 2007
DELTA SPINAL FUSION SYSTEM
K071857 · MNI
Jemo Spine, LLC
Orthopedic · 34d
Cleared Aug 08, 2007
RTX3370
K071953 · DRG
Rtx Healthcare A/S
Cardiovascular · 23d
Cleared Aug 08, 2007
CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML
K072037 · MEG
Life-Shield Products, Inc.
General Hospital · 14d
Cleared Aug 08, 2007
OSTEOGRAF/D-300
K072052 · LYC
Dentsply International, Inc.
Dental · 13d
Cleared Aug 07, 2007
KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING,...
K070360 · LFL
Kirwan Surgical Products, Inc.
General & Plastic Surgery · 181d
Cleared Aug 07, 2007
MASTER GUARD NITRILE BLUE POWDERED EXAMINATION GLOVES
K071207 · LZA
High Momentum Sdn Bhd
General Hospital · 98d
Cleared Aug 07, 2007
SBI RHEAD PLATING SYSTEM
K071549 · HRS
Small Bone Innovations, Inc.
Orthopedic · 62d
Cleared Aug 07, 2007
ARTHROCARE SYSTEM 12000
K071709 · GEI
Arthrocare Corp.
General & Plastic Surgery · 46d
Cleared Aug 07, 2007
DASH
K071775 · GAD
Ezsurgical
General & Plastic Surgery · 39d