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
137041–137064 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 29, 1988
DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE
K880411 · CAF
Dey Laboratories, Inc.
Anesthesiology · 28d
Cleared Feb 29, 1988
CEILING MOUNTED FLUOROSCOPIC C-ARM ARIEL C-ARM
K880527 · JAA
Fischer Imaging Corp.
Radiology · 20d
Cleared Feb 29, 1988
OVERHEAD TUBE MOUNT CASCADE II
K880528 · IYB
Fischer Imaging Corp.
Radiology · 20d
Cleared Feb 29, 1988
ELECTRONIC EPILATOR
K880553 · KCW
Clareblend, Inc.
General & Plastic Surgery · 20d
Cleared Feb 26, 1988
DECHERNEY HYSTEROSCOPY PUMP SYSTEM
K873527 · HIG
Cabot Medical Corp.
Obstetrics & Gynecology · 178d
Cleared Feb 26, 1988
BV105 (&BV105R) VASCULAR FLOW DETECTOR W/OPTIONAL
K873673 · DPT
Sonicaid, Inc.
Cardiovascular · 168d
Cleared Feb 26, 1988
VENT CORP PIB IMPLANT
K873818 · DZE
Core-Vent Corp.
Dental · 162d
Cleared Feb 26, 1988
ALKALINER
K873882 · EJK
Espe GmbH (Us)
Dental · 156d
Cleared Feb 26, 1988
SUNGLASSES (NONPRESCRIPTION)
K873966 · HQY
Swank Plus , Ltd.
Ophthalmic · 150d
Cleared Feb 26, 1988
SPECTACLE, MAGNIFYING
K873967 · HOT
Swank Plus , Ltd.
Ophthalmic · 150d
Cleared Feb 26, 1988
P2020 MOBILE C-ARM IMAGE INTENSIFIER
K874905 · JAA
Photo Medic Equipment, Inc.
Radiology · 87d
Cleared Feb 26, 1988
LABTICIAN RETINAL IMPLANTS
K875014 · HQJ
Labtician Products, Inc.
Ophthalmic · 84d
Cleared Feb 26, 1988
RUBBER CONTRACEPTIVE, LATEX CONDOMS
K875111 · HIS
Okamoto USA, Inc.
Obstetrics & Gynecology · 74d
Cleared Feb 26, 1988
INFRAGUIDE(TM)
K875115 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 74d
Cleared Feb 26, 1988
EXCEL REGULAR SET
K875141 · DYH
Reliance Orthodontic Products, Inc.
Dental · 73d
Cleared Feb 26, 1988
RELY-A-BOND(NO MIX ORTHODONTIC ADHESIVE)
K875143 · DYH
Reliance Orthodontic Products, Inc.
Dental · 73d
Cleared Feb 26, 1988
EXCEL FAST SET
K875144 · DYH
Reliance Orthodontic Products, Inc.
Dental · 73d
Cleared Feb 26, 1988
MAR BOND
K875145 · EBG
Reliance Orthodontic Products, Inc.
Dental · 73d
Cleared Feb 26, 1988
DB PRECISION IMPLANT SYSTEM, 1000 SERIES W/HAC
K875242 · DZE
Driskell Bioengineering
Dental · 66d
Cleared Feb 26, 1988
DB PRECISION IMPLANT SYSTEM, 2000 SERIES W/HAC
K875243 · DZE
Driskell Bioengineering
Dental · 66d
Cleared Feb 26, 1988
BISCOLOR
K875256 · EBF
Bisco, Inc.
Dental · 66d
Cleared Feb 26, 1988
PROFESSIONAL SERIES BIOFEEDBACK DEVICES MODEL 421
K875308 · HCC
Self Regulation Systems, Inc.
Neurology · 59d
Cleared Feb 26, 1988
HOSKINS-BARKAN GONIOTOMY LENS 10MM
K875330 · HJK
Ocular Instruments, Inc.
Ophthalmic · 58d
Cleared Feb 26, 1988
BICONCAVE VITRECTOMY LENS
K875331 · HJK
Ocular Instruments, Inc.
Ophthalmic · 58d