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
148873–148896 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 1985
COROMETRICS 115 FETAL MONITOR W/DUAL CARDIOTACHOME
K851252 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 56d
Cleared May 22, 1985
LOBESAFE PLAIN CONDOM DOZEN CONDOMS/BOX,PC-10
K851290 · HIS
Manexim Multicorp, Ltd.
Obstetrics & Gynecology · 51d
Cleared May 22, 1985
LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/BOX PC-30
K851291 · HIS
Manexim Multicorp, Ltd.
Obstetrics & Gynecology · 51d
Cleared May 22, 1985
AUSONICS 150
K851696 · IYO
Ausonics Pty , Ltd.
Radiology · 28d
Cleared May 22, 1985
61-100 TO 61-124 VARIOUS VAGINAL SPECVIA(CUSCO,GRA
K851799 · HDF
Artiberia
Obstetrics & Gynecology · 27d
Cleared May 22, 1985
STAPHAUREX ZL30
K851949 · GTN
Wellcome Diagnostics
Microbiology · 19d
Cleared May 22, 1985
INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAI
K852020 · HSB
Warsaw Orthopedic, Inc.
Orthopedic · 14d
Cleared May 22, 1985
FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVER
K852026 · HWC
Warsaw Orthopedic, Inc.
Orthopedic · 14d
Cleared May 22, 1985
PLAYTEX SLENDER REG. TAMPONS & DEODORANT TAMPONS
K852063 · HEB
Intl. Playtex, Inc.
Obstetrics & Gynecology · 9d
Cleared May 21, 1985
ACR 2500 CARDIOTOMY RESERVOIR FILTER
K842391 · DTN
Electromedics, Inc.
Cardiovascular · 337d
Cleared May 21, 1985
BUR, DENTAL GUTTA PERCHA-FILE-PULP CANAL
K842720 · EJL
Penn-Med Technology, Inc.
Dental · 312d
Cleared May 21, 1985
EVOKED RESPONSE ELECTRICAL STIMULATOR
K843226 · ETN
Nucleus, Ltd.
Ear, Nose, Throat · 278d
Cleared May 21, 1985
BIOGRAM
K843725 · JTN
Giles Scientific, Inc.
Microbiology · 239d
Cleared May 21, 1985
MICROTEK IRRIGATION SYSTEM
K844061 · GBX
Microtek Medical, Inc.
General & Plastic Surgery · 215d
Cleared May 21, 1985
VIROGEN RUBELLA MICROTITER TEST
K844436 · LQN
Armkel, LLC
Microbiology · 186d
Cleared May 21, 1985
QUANTUM 84
K844707 · GWF
Cadwell Laboratories, Inc.
Neurology · 169d
Cleared May 21, 1985
EUROPLATE-CONDUCTIVE ADHESIVE ELECTROSURGICAL RETU
K844780 · GEI
Poly- Med, Inc.
General & Plastic Surgery · 162d
Cleared May 21, 1985
OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT
K844854 · DQO
Vas-Cath of Canada , Ltd.
Cardiovascular · 159d
Cleared May 21, 1985
Z0174, IMPEDANCE AUDIOMETER
K845049 · ETY
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 176d
Cleared May 21, 1985
PROVAC WOUND HEALING/SUCTION SET
K850011 · GCY
Medical Matrix, Inc.
General & Plastic Surgery · 139d
Cleared May 21, 1985
AUTO TURNER
K850419 · FNM
George J. Kamilar
General Hospital · 106d
Cleared May 21, 1985
ABSORBABLE INTRACANALICULAR COLLAGEN IMPLANT
K850649
Lacrimedics, Inc.
Ophthalmic · 91d
Cleared May 21, 1985
ARGYLE GRIFFITH TDMAC HEPARINIZED VENO-VENOUS SHUN
K850917 · DWF
Sherwood Medical Co.
Cardiovascular · 77d
Cleared May 21, 1985
BLOOD TUBING(PVC) 201458 W/(TOTM) PLASTICIZER
K850925 · DWF
American Bentley
Cardiovascular · 77d