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
137449–137472 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 1988
GHAJAR GUIDE TWIST DRILL
K875018 · HBG
Neurodynamics, Inc.
Neurology · 55d
Cleared Jan 28, 1988
FOAM BORDERED DIAGNOSTIC (CARE) ELECTRODE
K875041 · DRX
Labeltape Meditect, Inc.
Cardiovascular · 56d
Cleared Jan 28, 1988
ACROMED ADS BONE NAIL DRIVER
K875054 · HWR
Buckman Co., Inc.
Orthopedic · 50d
Cleared Jan 28, 1988
HUDSON CRANINAL BURRS
K875224 · HBE
Tri-Med, Inc.
Neurology · 37d
Cleared Jan 28, 1988
MEDTRONIC SNAP EASE MODEL 7795 CUTANEOUS ELECTRODE
K875284 · GXY
Medtronic Vascular
Neurology · 35d
Cleared Jan 27, 1988
TELEFLEX STEERABLE GUIDEWIRE
K871850 · DQX
Teleflexmedical, Inc.
Cardiovascular · 260d
Cleared Jan 27, 1988
MODIFICATION TO ARKIVE(TM)
K872178 · BSZ
Diatek, Inc.
Anesthesiology · 233d
Cleared Jan 27, 1988
INTERMEDICS' NATURAL-KNEE(R) REVISION SYSTEM
K873602 · JWH
Intermedics Orthopedics
Orthopedic · 145d
Cleared Jan 27, 1988
MODEL 1859 TUMI/PRESSURE MODULE
K873695 · EXY
Life-Tech Intl., Inc.
Gastroenterology & Urology · 135d
Cleared Jan 27, 1988
ACID PHOSPHATASE TEST
K873726 · CKE
King Diagnostics, Inc.
Chemistry · 134d
Cleared Jan 27, 1988
SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP
K874093 · JDI
Protek, Inc.
Orthopedic · 111d
Cleared Jan 27, 1988
ZEISS 40 SL/P PHOTO SLIT LAMP
K874160 · HJO
Carl Zeiss, Inc.
Ophthalmic · 106d
Cleared Jan 27, 1988
AMERLITE FERRITIN ASSAY, LAN.0800/1800/2800
K874203 · DBF
Amersham Corp.
Immunology · 104d
Cleared Jan 27, 1988
KREDA DISC
K874252 · HOQ
Richmond Products, Inc.
Ophthalmic · 100d
Cleared Jan 27, 1988
CELLECT LABTRAK SOFTWARE
K874320 · GKL
Instrumentation Laboratory CO
Hematology · 98d
Cleared Jan 27, 1988
AUDIOMETRIC IMPEDANCE TESTER, MODEL Z02020
K874354 · ETY
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 96d
Cleared Jan 27, 1988
DONALDSON NATURAL EYEPATCH 'PATIENT PAK'
K874411 · HMP
Keeler Instruments, Inc.
General & Plastic Surgery · 91d
Cleared Jan 27, 1988
DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC
K874447 · DRO
Medac, Inc.
Cardiovascular · 91d
Cleared Jan 27, 1988
MODIFIED BIOVAC:LFA LASER FUME EVACUATION SYSTEM
K874512 · FYD
Stackhouse Assoc.
General Hospital · 86d
Cleared Jan 27, 1988
URETHRAL DILATOR ENDOSCOPE
K874530 · KOB
Advanced Surgical Intervention, Inc.
Gastroenterology & Urology · 85d
Cleared Jan 27, 1988
FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMS
K874607 · LKN
Organon Teknika Corp.
Gastroenterology & Urology · 79d
Cleared Jan 27, 1988
STEAM AUTOCLAVE CONTROL. & DATALOG. BY DATACON
K874644 · FLE
Pharmetics, Inc.
General Hospital · 75d
Cleared Jan 27, 1988
MMG CATHETER PLUG W/DRAINAGE TUBE COVER
K874682 · KOD
Medical Marketing Group
Gastroenterology & Urology · 75d
Cleared Jan 27, 1988
DENTAL HAND INSTRUMENTS
K874964 · EKJ
Solway, Inc.
Dental · 56d