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

Filters: Cleared only ×
176,076 results
62569–62592 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 08, 2006
HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801
K061047 · GKR
Hemocue AB
Hematology · 55d
Cleared Jun 08, 2006
DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT
K061144 · MBB
DePuy Orthopaedics, Inc.
Orthopedic · 44d
Cleared Jun 08, 2006
KINSA SUTURE ANCHOR
K061154 · MBI
Smith & Nephew, Inc.
Orthopedic · 43d
Cleared Jun 08, 2006
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM FOR THE UPPER EXTREMITY
K061352 · HRS
Smith & Nephew, Inc.
Orthopedic · 24d
Cleared Jun 08, 2006
RETAIN RADIOLUCENT SPACER
K061380 · MQP
Globus Medical, Inc.
Orthopedic · 21d
Cleared Jun 08, 2006
MEDELA VARIO SUCTION PUMPS
K061435 · OMP
Medela AG
General & Plastic Surgery · 15d
Cleared Jun 07, 2006
QUIX DIGITAL RADIOGRAPHIC UPGRADE
K052661 · MQB
Edge Medical Devices , Ltd.
Radiology · 253d
Cleared Jun 07, 2006
BRIVANT GUIDEWIRE
K060551 · DQX
Brivant Limited
Cardiovascular · 97d
Cleared Jun 07, 2006
TAG-IT CYSTIC FIBROSIS KIT
K060627 · NUA
Tm Bioscience Corporation
Pathology · 90d
Cleared Jun 07, 2006
DUTECK BODY COMPOSITION ANALYZER
K060642 · MNW
Duteck Industrial Co., Ltd.
Gastroenterology & Urology · 89d
Cleared Jun 07, 2006
CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060
K060820 · DXN
Suntech Medical, Inc.
Cardiovascular · 72d
Cleared Jun 07, 2006
POWDERED FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K060910 · LYZ
Jiangsu Everyguard Plastic Products...
General Hospital · 65d
Cleared Jun 07, 2006
PRECISION THUNIS 800+
K061028 · JAA
Ge Medical Systems, LLC
Radiology · 55d
Cleared Jun 07, 2006
20.1-INCH (51CM) COLOR LCD MONITOR CDL2009A (CCL204)
K061061 · LLZ
Tokotu Electric Co., Ltd.
Radiology · 51d
Cleared Jun 07, 2006
COHERENCE DOSIMETRIST, MODEL 2.2
K061097 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Jun 07, 2006
GLUCOMMANDER PLUS
K061110 · NDC
Collaborativemed, LLC
General Hospital · 48d
Cleared Jun 07, 2006
INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA...
K061163 · OWB
Ge Medical Systems, LLC
Radiology · 42d
Cleared Jun 07, 2006
WIEDENT ESTETIC
K061337 · ELM
Xpdent Corp
Dental · 26d
Cleared Jun 07, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN (GN) 0.5-32 UG/ML
K061355 · LON
Becton, Dickinson & CO
Microbiology · 23d
Cleared Jun 06, 2006
STOCKERT HEATER-COOLER SYSTEM 3T
K052601 · DWC
Sorin Group Deutschland GmbH
Cardiovascular · 258d
Cleared Jun 06, 2006
CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C
K052798 · LGN
Isovac Products, LLC
General Hospital · 246d
Cleared Jun 06, 2006
ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST
K053033 · DJC
Acro Biotech, LLC
Chemistry · 222d
Cleared Jun 06, 2006
ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST
K053034 · LDJ
Acro Biotech, LLC
Toxicology · 222d
Cleared Jun 06, 2006
VECTORVISION SPINE
K053159 · HAW
Brainlab AG
Neurology · 204d