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
137593–137616 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 15, 1988
SAFETY SHIELD KIT
K873731 · FXX
Ballard Medical Products
General Hospital · 158d
Cleared Jan 14, 1988
MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT.
K871712 · NVE
Machida America, Inc.
General Hospital · 255d
Cleared Jan 14, 1988
DEBRISAN ABSORBENT PAD
K872453 · KOZ
Pharmacia, Inc.
General & Plastic Surgery · 205d
Cleared Jan 14, 1988
PHARMANET (TM)
K872572 · EFQ
Pharmacia, Inc.
General & Plastic Surgery · 199d
Cleared Jan 14, 1988
OMNIFLEX NORMALIZED HIP STEM FOR PRESS-FIT FIXAT.
K872768 · KWA
Osteonics Corp.
Orthopedic · 184d
Cleared Jan 14, 1988
TYMPANIC TEMPERATURE SENSOR
K873205 · FLL
Respiratory Support Products, Inc.
General Hospital · 153d
Cleared Jan 14, 1988
ARTHROSCOPIC RETENTION-MANIPULATION SYSTEM (ARMS)
K873619 · HRX
Arthropedics, Inc.
Orthopedic · 128d
Cleared Jan 14, 1988
M-LENS (THIRTY DEGREE ENDOSCOPE)
K873795 · FEI
Opto Vision, Inc.
Gastroenterology & Urology · 119d
Cleared Jan 14, 1988
MX710 SERIES VASCULAR ACCESS INFUSION SET
K874133 · FPA
Medex, Inc.
General Hospital · 93d
Cleared Jan 14, 1988
HYPODERMIC NEEDLES, SINGLE LUMEN
K874414 · FMI
Harbor Medical Devices, Inc.
General Hospital · 78d
Cleared Jan 14, 1988
DYNAFILM
K874478 · NAD
Ferris Mfg. Corp.
General & Plastic Surgery · 73d
Cleared Jan 14, 1988
MODEL OPO-32 IRRIGATION SLEEVE
K874543 · EIB
Allergan, Inc.
Dental · 72d
Cleared Jan 14, 1988
ACE/FISCHER PERCUTANEOUS HALF PINS
K875012 · JDW
Buckman Co., Inc.
Orthopedic · 41d
Cleared Jan 14, 1988
ACE PERCUTANEOUS 3MM HALF-PINS
K875013 · JDW
Buckman Co., Inc.
Orthopedic · 41d
Cleared Jan 14, 1988
ACE/FISHER PERCUTANEOUS TRANSFIXING PINS
K875022 · JDW
Buckman Co., Inc.
Orthopedic · 41d
Cleared Jan 14, 1988
ORTHOMET BONE PLATES
K875086 · HRS
Orthomet, Inc.
Orthopedic · 36d
Cleared Jan 14, 1988
J&J SCALP VEIN INFUSION SETS
K875177 · FOZ
Critikon Company, LLC
General Hospital · 23d
Cleared Jan 14, 1988
ULTRA TAN PURPLE MINT
K875189 · LEJ
Ultra Tan Intl. AB
General & Plastic Surgery · 28d
Cleared Jan 14, 1988
ULTRA TAN PURPLE PRO
K875190 · LEJ
Ultra Tan Intl. AB
General & Plastic Surgery · 28d
Cleared Jan 13, 1988
SIEMENS SONODYNATOR 834, ULTRASOUND/STIMULATION
K872909 · IMG
Elmed, Inc.
Physical Medicine · 173d
Cleared Jan 12, 1988
SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS
K873168 · DRS
Spectramed, Inc.
Cardiovascular · 154d
Cleared Jan 12, 1988
OPTEC STAIN CHARACTERIZATION AND MODIFICATION KIT
K874162 · EBF
Pentron Corp.
Dental · 91d
Cleared Jan 12, 1988
PATTERN DISCRIMINATION PERIMETER
K874336 · HPT
Lkc Technologies, Inc.
Ophthalmic · 82d
Cleared Jan 12, 1988
ANGIOMED INTRODUCING SETS
K874771 · DWB
Angiomed U.S., Inc.
Cardiovascular · 54d