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
138769–138792 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 1987
OPTI-ZYME(R)
K873548 · LPN
Alcon Laboratories
Ophthalmic · 29d
Cleared Sep 29, 1987
U-IMPULSE AIR CONDUCTION IN-THE-CANAL HEARING AID
K873560 · ESD
Richards Medical Co., Inc.
Ear, Nose, Throat · 27d
Cleared Sep 29, 1987
TIF FECAL TEST
K873594 · LEA
Devetec, Inc.
Pathology · 25d
Cleared Sep 29, 1987
MICRO-CHEM ANALYZER
K873638 · JJQ
Ocean Scientific, Inc.
Chemistry · 20d
Cleared Sep 29, 1987
SPECTROPHOTOMETER (MICROASSAY PLATE READERS)
K873678 · JJQ
Slt Labinstruments, Inc.
Chemistry · 15d
Cleared Sep 29, 1987
ALKALINE PHOSPHATASE (ALK P) TESTPACK #67690/95
K873681 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 15d
Cleared Sep 28, 1987
UNIVERSAL JET VENTILATOR MODEL AMS-1000
K863155 · CBK
Acutronic Medical Systems AG
Anesthesiology · 409d
Cleared Sep 28, 1987
AUXILIARY CONTINUOUS WAVE DOPPLER TRANSDUCER
K871416 · JOP
Acuson Computed Sonography
Cardiovascular · 174d
Cleared Sep 28, 1987
ACUSON L538 TRANSDUCER
K871506 · JOP
Acuson Computed Sonography
Cardiovascular · 164d
Cleared Sep 28, 1987
H-H HUNTER ACTIVE TENDON IMPLANT PC
K872284 · HXA
Holter-Hausner Intl.
Orthopedic · 104d
Cleared Sep 28, 1987
H-H HUNTER ACTIVE TENDON IMPLANT DC
K872285 · HXA
Holter-Hausner Intl.
Orthopedic · 104d
Cleared Sep 28, 1987
H-H HUNTER ACTIVE TENDON IMPLANT BC
K872293 · HXA
Holter-Hausner Intl.
Orthopedic · 104d
Cleared Sep 28, 1987
MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERY
K872711 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 83d
Cleared Sep 28, 1987
SPERM-SELECT ADDITIONAL INDICATION
K872849 · HDR
Pharmacia, Inc.
Obstetrics & Gynecology · 70d
Cleared Sep 28, 1987
MOUTH TO FACE RESUSCITATOR
K873043 · BTM
Artec Environmental Monitoring Division
Anesthesiology · 55d
Cleared Sep 28, 1987
CEDAR(TM) RETRACTOR RING
K873691 · GZT
Cedar Surgical, Inc.
Neurology · 20d
Cleared Sep 25, 1987
TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500
K862970 · LDF
Medtronic Vascular
Cardiovascular · 415d
Cleared Sep 25, 1987
MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEM
K871711 · BZM
Medical Graphics Corp.
Anesthesiology · 147d
Cleared Sep 25, 1987
DOUBLE ANTIBODY ULTRA-PTH #KPTD1 AND KPTD2
K871970 · CEW
Diagnostic Products Corp.
Chemistry · 127d
Cleared Sep 25, 1987
ESCORT PORTABLE PATIENT MONITOR
K872291 · DXO
Medical Data Electronics
Cardiovascular · 101d
Cleared Sep 25, 1987
MODEL MICRO FD+ AMBULATORY ECG MONITOR
K872508 · DSH
Advanced Medical Products, Inc.
Cardiovascular · 93d
Cleared Sep 25, 1987
MODIFIED CAROTID SHUNT W/SPRING REINFORCED LUMEN
K872788 · DWF
Uresil Corp.
Cardiovascular · 73d
Cleared Sep 25, 1987
VASCULAR ACCESS PORT/CATH CAT. #VP-XXX VASPORT SER
K873035 · DQY
Gish Biomedical, Inc.
Cardiovascular · 52d
Cleared Sep 25, 1987
CYTOMEGALOVIRUS CONTROL SLIDES
K873114 · GQH
Medical Diagnostic Technologies, Inc.
Microbiology · 46d