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
76129–76152 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 31, 2002
SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06
K021379 · MNI
Ortho Tec, LLC
Orthopedic · 30d
Cleared May 31, 2002
HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED...
K021403 · MEH
Biomet Orthopedics, Inc.
Orthopedic · 29d
Cleared May 31, 2002
RPI REPLACEMENT PHOTOTHERAPY LIGHTS
K021531 · LBI
Replacement Parts Industries, Inc.
General Hospital · 21d
Cleared May 31, 2002
INTRACOIL SELF-EXPANDING PERIPHERAL STENT
K021563 · JCT
Sulzer Intratherapeutics, Inc.
General & Plastic Surgery · 18d
Cleared May 31, 2002
EN-SNARE ENDOVASCULAR SNARE AND CATHETER
K021606 · MMX
Medical Device Technologies, Inc.
Cardiovascular · 15d
Cleared May 31, 2002
SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES)
K021628 · IYN
Sonosite,Inc.
Radiology · 14d
Cleared May 30, 2002
LIGHTLANCE LASER SKIN PERFORATOR
K013021 · GEX
Innotech USA, Inc.
General & Plastic Surgery · 265d
Cleared May 30, 2002
ROSE K POST GRAFT LENS
K013646 · HQD
Rose K International , Ltd.
Ophthalmic · 206d
Cleared May 30, 2002
WAVE FORM MANUFACTURING PROLASE GENERAL SHAPED FIBER
K020673 · GEX
Wave Form Mfg., Inc.
General & Plastic Surgery · 90d
Cleared May 30, 2002
SS MATRIX
K020732 · KGN
Cook Biotech, Inc.
General & Plastic Surgery · 85d
Cleared May 30, 2002
SURX RF SYSTEM
K020952 · MUK
Surx, Inc.
Gastroenterology & Urology · 66d
Cleared May 30, 2002
IMMULITE 2000 SPECIFIC ALLERGENS
K021206 · DHB
Diagnostic Products Corp.
Immunology · 44d
Cleared May 30, 2002
IMMULITE 2000 MIXED ALLERGEN PANELS
K021208 · DHB
Diagnostic Products Corp.
Immunology · 44d
Cleared May 30, 2002
MODIFICATION TO ENTEC PLASMA WANDS
K021364 · GEI
Arthrocare Corp.
General & Plastic Surgery · 30d
Cleared May 30, 2002
TOESCO AQUA BLUE LED LIGHT CURING DEVICE
K021374 · EBZ
Toei Electric Co., Ltd.
Dental · 29d
Cleared May 30, 2002
ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A
K021587 · DQY
Medtronic Vascular
Cardiovascular · 15d
Cleared May 30, 2002
ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218
K021589 · DQY
Medtronic Vascular
Cardiovascular · 15d
Cleared May 30, 2002
DIGITAL CLINICAL THERMOMETER, MODELS ACT 2030, 2038
K021612 · FLL
Actherm, Inc.
General Hospital · 14d
Cleared May 30, 2002
DIGITAL CLINICAL THERMOMETER, MODEL ACT 3020
K021614 · FLL
Actherm, Inc.
General Hospital · 14d
Cleared May 29, 2002
MICRO-INDUCTION 1000 SYSTEM
K013615 · DPS
Harbinger Medical, Inc.
Cardiovascular · 205d
Cleared May 29, 2002
REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162,...
K020646 · DZE
Nobel Biocare Uas, Inc.
Dental · 90d
Cleared May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444
K021384 · DIF
Bio-Rad
Chemistry · 27d
Cleared May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463
K021411 · DIF
Bio-Rad
Chemistry · 26d
Cleared May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS...
K021414 · DIF
Bio-Rad
Chemistry · 26d