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
144001–144024 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 1986
PHENYTOIN (FPIA) CALIBRATOR KIT
K861770 · JIS
Windsor Laboratories, Inc.
Toxicology · 49d
Cleared Jun 25, 1986
FITTRONIC
K861796 · IPF
Corleone Intl. Traders, Inc.
Physical Medicine · 47d
Cleared Jun 25, 1986
TOBRAMYCIN (FPIA) CALIBRATOR KIT
K861891 · JIS
Windsor Laboratories, Inc.
Toxicology · 40d
Cleared Jun 25, 1986
SCOTCHBOND LIGHT CURED DENTAL ADHESIVE W/FLUORIDE
K861899 · EBF
3M Company
Dental · 40d
Cleared Jun 25, 1986
ULTRALITE HF1236 HAND AND FOOT SYSTEM
K861963 · FTC
Ultralite
General & Plastic Surgery · 36d
Cleared Jun 25, 1986
KHURI REGIONAL TISSUE PH MONITOR
K862114 · CBZ
Vascular Technology Incorporated
Anesthesiology · 22d
Cleared Jun 25, 1986
HYGEIA RAPID STREP A TEST
K862133 · GTY
Hygeia Sciences
Microbiology · 21d
Cleared Jun 25, 1986
X-MAT
K862144 · KXJ
Combined Concepts, Inc.
Radiology · 21d
Cleared Jun 25, 1986
ALT (SGPT) REAGENT SET (UV RATE)
K862209 · CKA
Sterling Diagnostics, Inc.
Chemistry · 15d
Cleared Jun 24, 1986
S80 IMPLANTABLE CARDIAC PACING LEAD
K854963 · DTB
Sorin Biomedica, Fiat, USA, Inc.
Cardiovascular · 195d
Cleared Jun 24, 1986
DELFIA (TM) HFSH KIT
K862043 · CGJ
Lkb Instruments, Inc.
Chemistry · 27d
Cleared Jun 23, 1986
ENTERNAL INFUSER MULTIPUMP 203
K861040 · FRN
Medix Medical Electronics (U.S.A.), Inc.
General Hospital · 97d
Cleared Jun 23, 1986
UCS-2, ULTRASONIC CLEANING SOLUTION
K861147 · FLG
Keymed, Inc.
General Hospital · 89d
Cleared Jun 23, 1986
PTT AUTOMATE TEST KIT
K861190 · GGW
American Bioproducts Co.
Hematology · 84d
Cleared Jun 23, 1986
STREAM-SWITCH MANIFOLD
K861209 · FRN
Intelligent Medicine, Inc.
General Hospital · 84d
Cleared Jun 23, 1986
SARNS PORTABLE POWER MODULE
K861388 · DTQ
3M Health Care, Sarns
Cardiovascular · 70d
Cleared Jun 23, 1986
ST-90 SPIRO ANALIZER
K861487 · BTY
Future Impex Corp.
Anesthesiology · 73d
Cleared Jun 23, 1986
MODEL PC HEARING AID
K861939 · ESD
Fine-Tune
Ear, Nose, Throat · 34d
Cleared Jun 23, 1986
PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM
K862021 · HQC
Ultramed, Inc.
Ophthalmic · 26d
Cleared Jun 23, 1986
MODEL HP HEARING AID
K862036 · ESD
Fine-Tune
Ear, Nose, Throat · 25d
Cleared Jun 23, 1986
LIFESOUND CUSTOM ITE
K862050 · ESD
Lifesounds, Inc.
Ear, Nose, Throat · 25d
Cleared Jun 23, 1986
DAHLBERG MODEL EE BEHIND-THE-EAR HEARING AID
K862099 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 21d
Cleared Jun 23, 1986
MODEL ED BEHIND-THE-EAR HEARING AID
K862100 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 21d
Cleared Jun 23, 1986
MODEL UM IN-THE-CANAL HEARING AID
K862101 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 21d