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
72673–72696 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 2003
COOL TOUCH 3
K031184 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 36d
Cleared May 21, 2003
RADIOMED SOFT TISSUE MARKER
K031206 · JAK
Radiomed Corp.
Radiology · 35d
Cleared May 21, 2003
CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G
K031447 · MQB
Canon, Inc.
Radiology · 14d
Cleared May 20, 2003
BODY CLOCK TENS N' TONE
K022849 · GZJ
Body Clock Health Care, Ltd.
Neurology · 266d
Cleared May 20, 2003
HOME CARE VAREIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-311, HT-311N, HT-312
K022998 · IPF
Home Care Technology Co., Ltd.
Physical Medicine · 253d
Cleared May 20, 2003
OSSATURA BCP BONE VOID FILLER
K030131 · MQV
Isotis NV
Orthopedic · 126d
Cleared May 20, 2003
COMFORT POWERED WHEELCHAIR, CONQUEROR LY-EB 202
K030355 · ITI
Comfort Orthopedic Co., Ltd.
Physical Medicine · 106d
Cleared May 20, 2003
COMFORT POWERED WHEELCHAIR, TRAVELLER LY-EB 103
K030356 · ITI
Comfort Orthopedic Co., Ltd.
Physical Medicine · 106d
Cleared May 20, 2003
SR-130
K030494 · IZL
Source-Ray, Inc.
Radiology · 90d
Cleared May 20, 2003
FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES,...
K030497 · KPO
Fresenius Medical Care
Gastroenterology & Urology · 90d
Cleared May 20, 2003
14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55
K030502 · MSD
Medcomp
Gastroenterology & Urology · 90d
Cleared May 20, 2003
T.E.A.R. TECH3 MODEL #44TT03
K030507 · IPF
Vision Quest Industries, Inc.
Physical Medicine · 90d
Cleared May 20, 2003
DEPILASE TRIO LASE LASER SYSTEM
K030508 · GEX
Depilase Group , Ltd.
General & Plastic Surgery · 90d
Cleared May 20, 2003
AMERITEK SURE-POINT TRACKER SYSTEM
K030518 · ITX
Amertek Medical, Inc.
Radiology · 90d
Cleared May 20, 2003
LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS
K030527 · GEX
Lumenis
General & Plastic Surgery · 90d
Cleared May 20, 2003
CALLOS
K030554 · MQV
Skeletal Kinetics, LLC
Orthopedic · 88d
Cleared May 20, 2003
EVERSTICK POST
K030820 · ELR
Stick Tech , Ltd.
Dental · 67d
Cleared May 20, 2003
SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM...
K031053 · EGJ
Selectivemed Components, Inc.
Physical Medicine · 48d
Cleared May 20, 2003
DISPOSABLE POWDERED VINYL EXAM GLOVES
K031134 · LYZ
Elite International, Inc.
General Hospital · 41d
Cleared May 20, 2003
C.T.M. MOBILITY SCOOTER, MODEL HS-120
K031272 · INI
C.T.M. Homecare Product, Inc.
Physical Medicine · 28d
Cleared May 20, 2003
IS-1 HEMOSTASIS VALVE, MODEL 6799
K031398 · DTL
Guidant Corp.
Cardiovascular · 15d
Cleared May 20, 2003
ROSS EMBRACE ENTERAL PUMP
K031407 · LZH
Ross Product Div. Abbott Laboratories
General Hospital · 15d
Cleared May 19, 2003
ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH
K030631 · FTL
Prosurg, Inc.
General & Plastic Surgery · 80d
Cleared May 19, 2003
DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC,...
K030952 · DQA
Dolphin Medical, Inc.
Anesthesiology · 54d