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
79753–79776 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 2001
SPINAL EPIDURAL NEEDLES
K002405 · BSP
Te ME NA S.A.R.L.
Anesthesiology · 298d
Cleared Jun 01, 2001
JET SYRINGE MODEL-100500
K003741 · KZE
Equidyne Systems, Inc.
General Hospital · 179d
Cleared Jun 01, 2001
RESPIRATORY HUMIDIFIER, MODEL HC150
K003973 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 161d
Cleared Jun 01, 2001
PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
K003992 · NFA
Percu Surge, Inc.
Cardiovascular · 157d
Cleared Jun 01, 2001
KOKO PEAK KP
K010009 · BZH
Pds Healthcare Products, Inc.
Anesthesiology · 150d
Cleared Jun 01, 2001
VERDICT -II METHAMPHETAMINE
K010226 · DJC
Medtox Diagnostics, Inc.
Toxicology · 128d
Cleared Jun 01, 2001
ISCREEN VISION SCREENER
K010315 · HKI
Iscreen, LLC
Ophthalmic · 119d
Cleared Jun 01, 2001
DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
K011020 · KPM
Denver Biomedicals, Inc.
Gastroenterology & Urology · 58d
Cleared Jun 01, 2001
CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
K011366 · KLW
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 28d
Cleared Jun 01, 2001
SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP
K011587 · LZH
Entracon Corp.
General Hospital · 9d
Cleared May 31, 2001
ESU HANDSWITCHING PENCIL
K001442 · GEI
Surgex, Inc.
General & Plastic Surgery · 388d
Cleared May 31, 2001
CADHEALTH SYSTEM, MODEL CHP-001
K002514 · DRG
Caduceus Health Care , Ltd.
Cardiovascular · 289d
Cleared May 31, 2001
INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX
K002847 · DYB
Maxxim Medical
Cardiovascular · 260d
Cleared May 31, 2001
NAT - NUCLEIC ACID TRANSPORT
K003761 · LIO
Medical Packaging Corp.
Microbiology · 176d
Cleared May 31, 2001
LAPAROSCOPIC HAND PORT
K003871 · GCJ
Applied Medical Resources Corp.
General & Plastic Surgery · 167d
Cleared May 31, 2001
BUTTERFLY PLATE FUNCTION SYSTEM
K010632 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 90d
Cleared May 31, 2001
VERSYO.COM
K010800 · EBI
Heraeus Kulzer, Inc.
Dental · 76d
Cleared May 31, 2001
AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY
K010865 · FLE
STERIS Corporation
General Hospital · 70d
Cleared May 31, 2001
ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145
K010898 · LFL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 66d
Cleared May 31, 2001
X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN...
K010961 · LYY
Ansell Healthcare Products, Inc.
General Hospital · 62d
Cleared May 31, 2001
OSTEOBELL
K011104 · KNW
Biopsybell S.A.S.
Gastroenterology & Urology · 50d
Cleared May 31, 2001
VASOTRAC APM205A
K011152 · DXN
Medwave, Inc.
Cardiovascular · 45d
Cleared May 31, 2001
POWDER-FREE VINYL EXAM GLOVES
K011412 · LYZ
Heyuan Hongli Industries, Inc.
General Hospital · 23d
Cleared May 31, 2001
ACTIWARE-PLMS
K011430 · GWQ
Mini-Mitter Co., Inc.
Neurology · 22d