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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
139609–139632 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 15, 1987
ULTRASOUND TRANSDUCER SHEATHS, STERILE
K871609 · ITX
Amedic USA
Radiology · 82d
Cleared Jul 15, 1987
HCG MAB SOLID PHASE COMPONENT SYSTEM
K871700 · JHI
Bd Becton Dickinson Vacutainer...
Chemistry · 75d
Cleared Jul 15, 1987
CONDUCTIVITY GEL
K871913 · GYB
Futuremed Div. of Future Impex Corp.
Neurology · 58d
Cleared Jul 15, 1987
CONDUCTIVITY GEL
K872045 · GYB
Futuremed Div. of Future Impex Corp.
Neurology · 49d
Cleared Jul 15, 1987
MODEL 3000 OPHTHALMIC SURGICAL SYSTEM
K872312 · HQE
Allergan Humphrey
Ophthalmic · 92d
Cleared Jul 15, 1987
TRANSWORLD 360V, MODEL A1-4040
K872357 · IZO
Transworld X-Ray Corp.
Radiology · 27d
Cleared Jul 15, 1987
PRECISION SCREW DRIVER SET
K872389 · HXX
Med-Tool, Inc.
Orthopedic · 26d
Cleared Jul 15, 1987
CENTRALITE
K872489 · IWE
Diacor, Inc.
Radiology · 22d
Cleared Jul 15, 1987
CURETTE SET, ANTRUM, COAKLEY
K872609 · KAP
Military Engineering, Inc.
Ear, Nose, Throat · 9d
Cleared Jul 14, 1987
GENDER CHOICE INFORMATION KIT, FEMALE AND MALE
K870999 · LHD
Procare C/O Wiley, Rein & Fielding
Obstetrics & Gynecology · 125d
Cleared Jul 14, 1987
CIVCO STEPPER
K871413 · FZX
CIVCO Medical Instruments Co., Inc.
General & Plastic Surgery · 97d
Cleared Jul 14, 1987
KONTOUR ULTRA SOFT SPONGE #SS144.50
K872069 · NAD
Winfield Laboratories, Inc.
General & Plastic Surgery · 46d
Cleared Jul 14, 1987
TAMPAX DEODORANT TAMPON, SUPER
K872261 · HIL
Tambrands, Inc.
Obstetrics & Gynecology · 34d
Cleared Jul 13, 1987
FETALFLEX FETAL ELECTRODE
K871079 · HGP
Epcom Medical Systems, Inc.
Obstetrics & Gynecology · 117d
Cleared Jul 13, 1987
ZWEYMUELLER-SL HIP PROSTHESIS STEM
K871453 · KWA
Allo Pro Corp.
Orthopedic · 91d
Cleared Jul 13, 1987
SWEET VERNAL ALLERGEN DISC
K871723 · DHB
Incstar Corp.
Immunology · 70d
Cleared Jul 13, 1987
PORT ACCESS KITS
K872011 · LRO
The Jarid Group, Inc.
General & Plastic Surgery · 48d
Cleared Jul 10, 1987
TOMOMATIC 232
K862511 · KPS
Medimatic
Radiology · 374d
Cleared Jul 10, 1987
TEKNAR PROSCAN(TM)
K864807 · IYO
Teknar, Inc.
Radiology · 213d
Cleared Jul 10, 1987
ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER
K870773 · LLF
Hgm, Inc.
Neurology · 134d
Cleared Jul 10, 1987
BIOPSY NEEDLE GUIDE KIT, STERILE
K871503 · FZX
Amedic USA
General & Plastic Surgery · 84d
Cleared Jul 10, 1987
MODEL 26021C BIPOLAR COAGULATOR
K871745 · HIN
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 66d
Cleared Jul 10, 1987
POST. SCREW & HEX DRIVER/ADBUT & ADBUT HEAD DRIVER
K871862 · DZE
Implant Innovations International, Inc.
Dental · 58d
Cleared Jul 10, 1987
ADBUTMENT CYLINDER AND SCREW
K871863 · DZE
Implant Innovations International, Inc.
Dental · 58d